Trial Outcomes & Findings for In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for up to 7 Days (NCT NCT04022889)
NCT ID: NCT04022889
Last Updated: 2022-10-27
Results Overview
Recovery of Test platelets stored for 7 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is \>66% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test-0.66\*Control) in survival is greater than or equal to zero.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 7 days and fresh Control platelets
Results posted on
2022-10-27
Participant Flow
A subject was considered "enrolled" upon signing the informed consent form.
Subjects who initiated an apheresis collection were included in the Safety Analysis Set. Subjects with paired Test and Control in vivo recovery and survival data were included in the Evaluable Analysis Set. Data from subjects who completed a Variant 1 arm of Stage 1 was included as part of the Stage 2 analysis.
Participant milestones
| Measure |
Stage 1- BEST - Variant 1
Stage 1 is a randomized, 2-period crossover design. Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on either the BEST or Variant 1 methods (depending on the period and randomization scheme for the Test platelets) for 12 healthy subjects.
A subject was considered "enrolled" upon signing the informed consent form. The Safety Analysis Set comprised all subjects who initiated an apheresis collection.
|
Stage 1- Variant 1 BEST
Stage 1 is a randomized, 2-period crossover design. Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on either the BEST or Variant 1 methods (depending on the period and randomization scheme for the Test platelets) for 12 healthy subjects.
A subject was considered "enrolled" upon signing the informed consent form. The Safety Analysis Set comprised all subjects who initiated an apheresis collection.
|
Stage 2-Variant 1
Stage 2 was a single arm design. Test (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) platelets stored for 7 days, were prepared for radiolabeling following the Variant 1 methodology. The recovery and survival for Test platelets was compared against the fresh platelet Control. A subject was considered "enrolled" upon signing the informed consent form. The Safety Analysis Set comprised all subjects who initiated an apheresis collection. Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|
|
Stage 1: Period 1
STARTED
|
9
|
6
|
0
|
|
Stage 1: Period 1
Met Screening Criteria
|
9
|
6
|
0
|
|
Stage 1: Period 1
Successful Apheresis Collection
|
8
|
6
|
0
|
|
Stage 1: Period 1
Completed 7-days Storage of Test Platelet Component
|
7
|
6
|
0
|
|
Stage 1: Period 1
Completed Post Infusion Sampling
|
7
|
6
|
0
|
|
Stage 1: Period 1
COMPLETED
|
7
|
6
|
0
|
|
Stage 1: Period 1
NOT COMPLETED
|
2
|
0
|
0
|
|
Stage 1: Period 2
STARTED
|
7
|
6
|
0
|
|
Stage 1: Period 2
Met Screening Criteria
|
7
|
6
|
0
|
|
Stage 1: Period 2
Successful Apheresis Collection
|
7
|
6
|
0
|
|
Stage 1: Period 2
Completed 7-days Storage of Test Platelet Component
|
7
|
6
|
0
|
|
Stage 1: Period 2
Completed Post Infusion Sampling
|
6
|
5
|
0
|
|
Stage 1: Period 2
COMPLETED
|
6
|
5
|
0
|
|
Stage 1: Period 2
NOT COMPLETED
|
1
|
1
|
0
|
|
Stage 2
STARTED
|
7
|
6
|
22
|
|
Stage 2
Met Screening Criteria
|
7
|
6
|
19
|
|
Stage 2
Successful Apheresis Collection
|
7
|
6
|
15
|
|
Stage 2
Completed 7-days Storage of Test Platelet Component
|
7
|
6
|
14
|
|
Stage 2
Completed Post Infusion Sampling
|
6
|
6
|
14
|
|
Stage 2
COMPLETED
|
6
|
6
|
14
|
|
Stage 2
NOT COMPLETED
|
1
|
0
|
8
|
Reasons for withdrawal
| Measure |
Stage 1- BEST - Variant 1
Stage 1 is a randomized, 2-period crossover design. Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on either the BEST or Variant 1 methods (depending on the period and randomization scheme for the Test platelets) for 12 healthy subjects.
A subject was considered "enrolled" upon signing the informed consent form. The Safety Analysis Set comprised all subjects who initiated an apheresis collection.
|
Stage 1- Variant 1 BEST
Stage 1 is a randomized, 2-period crossover design. Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on either the BEST or Variant 1 methods (depending on the period and randomization scheme for the Test platelets) for 12 healthy subjects.
A subject was considered "enrolled" upon signing the informed consent form. The Safety Analysis Set comprised all subjects who initiated an apheresis collection.
|
Stage 2-Variant 1
Stage 2 was a single arm design. Test (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) platelets stored for 7 days, were prepared for radiolabeling following the Variant 1 methodology. The recovery and survival for Test platelets was compared against the fresh platelet Control. A subject was considered "enrolled" upon signing the informed consent form. The Safety Analysis Set comprised all subjects who initiated an apheresis collection. Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|
|
Stage 1: Period 1
Adverse Event
|
1
|
0
|
0
|
|
Stage 1: Period 1
Platelet component did not meet input specifications
|
1
|
0
|
0
|
|
Stage 1: Period 2
Site closure due to COVID-19 pandemic
|
1
|
1
|
0
|
|
Stage 2
Screen Failure
|
0
|
0
|
3
|
|
Stage 2
Ineligible for apheresis donation
|
0
|
0
|
2
|
|
Stage 2
Adverse Event
|
0
|
0
|
2
|
|
Stage 2
Protocol Violation
|
0
|
0
|
1
|
|
Stage 2
Site closure due to COVID-19 pandemic
|
1
|
0
|
0
|
Baseline Characteristics
In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for up to 7 Days
Baseline characteristics by cohort
| Measure |
Stage 1
n=15 Participants
Stage 1 was comprised of a randomized 2-arm, 2-period crossover design (Period 1 and Period 2). Each subject was randomized to Arm 1 or 2 of the study to determine which methodology was used in Period 1 and Period 2 to prepare and radiolabel the Test platelets. In Arm 1, Test platelets were radiolabeled using the Variant 1 method in Period 1 and the BEST method in Period 2. Test platelets in Arm 2 were radiolabeled using the BEST method in Period 1 and the Variant 1 method in Period 2.
Test platelets were derived from apheresis platelet components in 100% plasma, collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets and stored for 7 days.
The recovery and survival for Test platelets was compared against the fresh platelet Control.
A subject was considered "enrolled" upon signing the informed consent form. Demographics are summarized for the Safety Analysis Set which was comprised all subjects who initiated an apheresis collection for Stage 1.
|
Stage 2
n=17 Participants
Stage 2 was comprised of a single period. Test platelets were derived from apheresis platelet components in 100% plasma, collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets and stored for 7 days. On Day 7 Test platelets were prepared for radiolabeling following the Variant 1 methodology. The recovery and survival for Test platelets was compared against the fresh platelet Control. A subject was considered "enrolled" upon signing the informed consent form. Safety Analysis Set which comprised all subjects who initiated an apheresis collection; the Safety Analysis Set for Stage 2 comprised 12 Stage 1 subjects with evaluable Variant 1 method data and 17 new Stage 2 subjects. Demographics are summarized for the 17 new Stage 2 subjects.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
36.5 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
40.9 years
STANDARD_DEVIATION 16.2 • n=7 Participants
|
38.9 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Height
|
180 cm
STANDARD_DEVIATION 8 • n=5 Participants
|
172 cm
STANDARD_DEVIATION 7 • n=7 Participants
|
176 cm
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Weight
|
93 kg
STANDARD_DEVIATION 16 • n=5 Participants
|
85 kg
STANDARD_DEVIATION 16 • n=7 Participants
|
88 kg
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Blood Type
A
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Blood Type
B
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Blood Type
O
|
6 participants
n=5 Participants
|
10 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Blood Type
AB
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Rh Factor
Negative
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Rh Factor
Positive
|
12 participants
n=5 Participants
|
15 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
BMI
|
29 kg/m^2
n=5 Participants
|
29 kg/m^2
n=7 Participants
|
29 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 7 days and fresh Control plateletsPopulation: The Evaluable Analysis Set (EAS) comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation. EAS was the primary analysis population for the efficacy evaluation.
Recovery of Test platelets stored for 7 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is \>66% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test-0.66\*Control) in survival is greater than or equal to zero.
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=12 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=12 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=12 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
n=12 Participants
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
n=23 Participants
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Post Infusion Recovery of Test Platelets at End of Storage (Day 7)
|
57.8 percentage of infused platelets
Standard Deviation 11.6
|
39.5 percentage of infused platelets
Standard Deviation 10.3
|
39.1 percentage of infused platelets
Standard Deviation 10.6
|
60.4 percentage of infused platelets
Standard Deviation 10.5
|
37.6 percentage of infused platelets
Standard Deviation 8.4
|
56.8 percentage of infused platelets
Standard Deviation 9.2
|
PRIMARY outcome
Timeframe: 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 7 days and fresh Control plateletsPopulation: The Evaluable Analysis Set (EAS) comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation. EAS was the primary analysis population for the efficacy evaluation.
Survival of Test platelets stored for 7 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is \>58% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 \* Control) in survival is greater than or equal to zero.
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=12 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=12 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=12 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
n=12 Participants
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
n=23 Participants
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Post Infusion Survival of Test Platelets at End of Storage
|
208.9 hours
Standard Deviation 15.8
|
150.1 hours
Standard Deviation 21.6
|
143.2 hours
Standard Deviation 33.6
|
202.9 hours
Standard Deviation 24.4
|
151.4 hours
Standard Deviation 20.1
|
209.6 hours
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: At the end of INTERCEPT treatment on Day 1 or Day 2Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Percentage of Test components with ≥ 3.0×10\^11 platelets
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Platelet Dose in Test Component
|
13 Participants
|
12 Participants
|
22 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At the end of INTERCEPT treatment on Day 1 or Day 2Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Percentage of Test components with ≥80% platelet yield retention
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Platelet Yield Retention
|
12 Participants
|
12 Participants
|
22 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Percentage of Test components with pH 22°C ≥ 6.2
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
pH 22°C
|
13 Participants
|
13 Participants
|
23 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Component volume was summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Component Volume
|
338 mL
Standard Deviation 12
|
334 mL
Standard Deviation 17
|
330 mL
Standard Deviation 20
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Platelet count was summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Platelet Count
|
1086 ×10^3 platelets/µL
Standard Deviation 112
|
1116 ×10^3 platelets/µL
Standard Deviation 185
|
1133 ×10^3 platelets/µL
Standard Deviation 176
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Platelet dose was summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Platelet Dose
|
3.7 ×10^11 platelets
Standard Deviation 0.4
|
3.7 ×10^11 platelets
Standard Deviation 0.7
|
3.7 ×10^11 platelets
Standard Deviation 0.5
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
MPV was summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: MPV
|
7.2 fL
Standard Deviation 0.7
|
7.3 fL
Standard Deviation 0.6
|
7.0 fL
Standard Deviation 0.7
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
pO2 was summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: pO2
|
147.2 mm Hg
Standard Deviation 13.8
|
152.2 mm Hg
Standard Deviation 7.6
|
152.3 mm Hg
Standard Deviation 8.3
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
pO2 normalized for platelet count was summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized pO2
|
42.4 µmol/hrs/10^12 platelets
Standard Deviation 7.3
|
43.5 µmol/hrs/10^12 platelets
Standard Deviation 10.6
|
42.5 µmol/hrs/10^12 platelets
Standard Deviation 8.4
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
pCO2 was summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: pCO2
|
27.4 mm Hg
Standard Deviation 2.3
|
26.5 mm Hg
Standard Deviation 3.1
|
26.3 mm Hg
Standard Deviation 2.8
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
pCO2 was normalized for platelet count and summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized pCO2
|
7.8 µmol/hrs/10^12 platelets
Standard Deviation 0.6
|
7.4 µmol/hrs/10^12 platelets
Standard Deviation 1.0
|
7.3 µmol/hrs/10^12 platelets
Standard Deviation 1.3
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
HCO3 was summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: HCO3
|
7.0 mmol/L
Standard Deviation 1.7
|
7.4 mmol/L
Standard Deviation 2.3
|
7.1 mmol/L
Standard Deviation 2.1
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
HCO3 was normalized for platelet count and was summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized HCO3
|
6.5 mmol/10^12 platelets
Standard Deviation 1.6
|
6.8 mmol/10^12 platelets
Standard Deviation 2.7
|
6.5 mmol/10^12 platelets
Standard Deviation 2.5
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Supernatant glucose was summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Glucose
|
12.0 mmol/L
Standard Deviation 2.2
|
12.0 mmol/L
Standard Deviation 2.4
|
12.2 mmol/L
Standard Deviation 3.9
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Supernatant glucose was normalized for platelet count and summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant Glucose
|
11.1 mmol/10^12 platelets
Standard Deviation 2.0
|
11.3 mmol/10^12 platelets
Standard Deviation 4.2
|
11.2 mmol/10^12 platelets
Standard Deviation 4.4
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Supernatant lactate was summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=22 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Lactate
|
11.1 mmol/L
Standard Deviation 2.8
|
11.6 mmol/L
Standard Deviation 3.1
|
12.3 mmol/L
Standard Deviation 2.8
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Supernatant lactate was normalized for platelet count and summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=22 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant Lactate
|
10.4 mmol/10^12 platelets
Standard Deviation 3.1
|
10.7 mmol/10^12 platelets
Standard Deviation 3.4
|
11.1 mmol/10^12 platelets
Standard Deviation 2.8
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Total ATP was summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Total ATP
|
3.0 µmol/dL
Standard Deviation 1.5
|
3.5 µmol/dL
Standard Deviation 2.1
|
4.0 µmol/dL
Standard Deviation 2.0
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Total ATP was normalized for platelet count and summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Total ATP
|
2.8 nmol/10^8 platelets
Standard Deviation 1.5
|
3.2 nmol/10^8 platelets
Standard Deviation 2.0
|
3.5 nmol/10^8 platelets
Standard Deviation 1.7
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
The morphology score quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher morphology scores represent healthier platelets. Morphology was summarized descriptively for Stage 1 and Stage 2 Test components.
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Morphology
|
326 score on a scale
Standard Deviation 31
|
327 score on a scale
Standard Deviation 21
|
324 score on a scale
Standard Deviation 22
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
The Extent of Shape Change is a measurement of agonist-induced, disc-to-sphere shape change of platelets using an aggregometer. It is a quantitative assessment of the proportion of platelets that have discoid morphology in a platelet suspension. Higher values indicate better platelet quality. An aggregometer instrument is to make this measurement. Extent of Shape Change was summarized descriptively for Stage 1 and Stage 2 Test components.
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Extent of Shape Change
|
21.5 percentage of extent of shape change
Standard Deviation 8.2
|
18.3 percentage of extent of shape change
Standard Deviation 6.7
|
16.8 percentage of extent of shape change
Standard Deviation 5.5
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Hypotonic Shock Response is used as an index of platelet integrity and metabolic homeostasis. An aggregometer instrument was used to measure the ability of platelets to recover their volume after being exposed to a hypotonic environment. Higher values of Hypotonic Shock Response indicate better platelet quality. Hypotonic Shock Response was summarized descriptively for Stage 1 and Stage 2 Test components.
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Hypotonic Shock Response
|
53.4 percentage of hypotonic shock response
Standard Deviation 9.1
|
45.8 percentage of hypotonic shock response
Standard Deviation 14.2
|
48.6 percentage of hypotonic shock response
Standard Deviation 16.9
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Supernatant levels of LDH in PCs represent normal plasma LDH plus LDH released by platelets through cell leakage and injury. Supernatant LDH activity was summarized descriptively for Stage 1 and Stage 2 Test components.
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Lactate Dehydrogenase (LDH) Activity
|
235 U/L
Standard Deviation 54
|
238 U/L
Standard Deviation 70
|
238 U/L
Standard Deviation 86
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Supernatant LDH activity was normalized for platelet count and was summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant LDH
|
220 U/10^12 platelets
Standard Deviation 62
|
222 U/10^12 platelets
Standard Deviation 87
|
217 U/10^12 platelets
Standard Deviation 90
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Total LDH activity was normalized for platelet count and was summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Total LDH Activity
|
2294 U/L
Standard Deviation 537
|
2278 U/L
Standard Deviation 458
|
2398 U/L
Standard Deviation 482
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Supernatant LDH Proportion of Total LDH, ratio of LDH supernatant to the total LDH, was summarized descriptively for Stage 1 and Stage 2 Test components
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant LDH Proportion of Total LDH
|
10.6 percentage of cell free LDH to total LDH
Standard Deviation 3.3
|
10.7 percentage of cell free LDH to total LDH
Standard Deviation 3.1
|
10.1 percentage of cell free LDH to total LDH
Standard Deviation 3.4
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
For calculation of baseline adjusted lysis the baseline/input supernatant LDH is subtract from the Day 7 supernatant LDH; the lysis is calculated from from the Day 7 adjusted supernatant LDH and Day 7 total LDH values. Baseline Adjusted Lysis was summarized descriptively for Stage 1 and Stage 2 Test components.
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: Baseline Adjusted Lysis
|
4.6 - % of cell free LDH increased from base
Standard Deviation 2.9
|
4.7 - % of cell free LDH increased from base
Standard Deviation 2.7
|
4.4 - % of cell free LDH increased from base
Standard Deviation 2.9
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 7Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Measurement of P-selectin (CD62P) exposure is often used as an index of platelet activation as it is translocated from the alpha granule to the plasma membrane during platelet secretion. This is a sensitive assay to quantify platelet potential for activation. Higher levels of P-selectin indicate more activation. P-selectin was measured by flow cytometry and was summarized descriptively for Stage 1 and Stage 2 Test components.
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
Assessment of the Stored Test (INTERCEPT) Platelet Components: P-selectin (CD62P)
|
45.3 percentage of CD62P platelets
Standard Deviation 18.2
|
44.7 percentage of CD62P platelets
Standard Deviation 19.4
|
52.2 percentage of CD62P platelets
Standard Deviation 16.5
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 7Population: Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Stage 1 and Stage 2 sample volume from platelet component was summarized descriptively for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures.
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Sample Volume From Component
|
45.4 mL
Standard Deviation 15.4
|
46.8 mL
Standard Deviation 13.8
|
42.9 mL
Standard Deviation 14.9
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 7Population: Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Stage 1 and Stage 2 platelet count was summarized descriptively for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures.
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Platelet Count
|
3938 ×10^3 platelets/µL
Standard Deviation 856
|
5368 ×10^3 platelets/µL
Standard Deviation 868
|
5265 ×10^3 platelets/µL
Standard Deviation 1128
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 7Population: Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
In vitro physical platelet recovery is expressed as the percentage of platelets that are remaining after preparation of the Test sample for radiolabeling, prior to addition of the radiolabel, compared to the number of platelets that were present prior to sample preparation. This measurement shows the loss of platelets during the sample preparations and also provides a process control parameter to ensure that the platelet sample used for radiolabeling is representative of the platelet population in the entire platelet component. Stage 1 and Stage 2 Platelet Yield (Physical Recovery) was summarized descriptively for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures.
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Platelet Yield (Physical Recovery)
|
67.7 percentage of physical recovery
Standard Deviation 12.2
|
85.2 percentage of physical recovery
Standard Deviation 6.8
|
84.4 percentage of physical recovery
Standard Deviation 6.8
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 7Population: Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
The percentage of Stage 1 and Stage 2 samples with physical recovery ≥ 80% was summarized for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures.
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=12 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Percentage of Samples With Physical Recovery ≥ 80%
|
1 Participants
|
11 Participants
|
16 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 7Population: Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Stage 1 and Stage 2 pH 22°C was summarized descriptively for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures.
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: pH 22°C
|
6.1 pH unit
Standard Deviation 0.4
|
6.3 pH unit
Standard Deviation 0.3
|
6.3 pH unit
Standard Deviation 0.2
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 7Population: Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
The percentage of Stage 1 and Stage 2 samples with pH 22°C ≥ 6.2 was summarized for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures.
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
n=23 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Percentage of Samples With pH 22°C ≥ 6.2
|
8 Participants
|
8 Participants
|
18 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 7Population: Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
The Red Blood Cell Total Count was summarized descriptively for Test samples processed using both the BEST and Variant 1 procedures in Stage 1.
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=12 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Red Blood Cell Total Count
|
176 cells
Standard Deviation 324
|
212 cells
Standard Deviation 456
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 7Population: Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
The White Blood Cell Total Count was summarized descriptively for Test samples processed using both the BEST and Variant 1 procedures in Stage 1.
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=12 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: White Blood Cell Total Count
|
722 cells
Standard Deviation 629
|
2666 cells
Standard Deviation 3104
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 7Population: Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
Measurement of P-selectin (CD62P) exposure is often used as an index of platelet activation as it is translocated from the alpha granule to the plasma membrane during platelet secretion. This is a sensitive assay to quantify platelet potential for activation. Higher levels of P-selectin indicate more activation. Measurement of P-selectin prior to radiolabeling allows assessment of the amount of platelet activation induced by the sample preparation process when compared to the Day 7 P-selectin levels in the platelet component. The P-selectin expression (CD62P) was summarized descriptively for Test samples processed using both the BEST and Variant 1 procedures in Stage 1.
Outcome measures
| Measure |
Stage 1 - BEST Arm
n=13 Participants
Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
|
Stage 1 - Variant 1 Arm - TEST
n=13 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
|
Stage 1 - BEST Arm- TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
|
Stage 1 - BEST Arm - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
|
Stage 2 - TEST
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
Stage 2 - CONTROL
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
|
|---|---|---|---|---|---|---|
|
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: P-selectin Expression (CD62P)
|
67.2 percentage of CD62P platelets
Standard Deviation 17.7
|
54.2 percentage of CD62P platelets
Standard Deviation 21.5
|
—
|
—
|
—
|
—
|
Adverse Events
Stage 1-Variant 1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Stage 1-BEST
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Stage 2-Variant 1
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stage 1-Variant 1
n=13 participants at risk
The study was performed in two stages. Stage 1 was a randomized, 2-period crossover design. Test platelets stored for 7 days were radiolabeled based on either the BEST or Variant 1 methods (depending on the period and randomization scheme for the Test platelets) for 12 healthy subjects. The recovery and survival for Test platelets prepared with the BEST and Variant 1 methods was compared with each other and against the fresh platelet Control. With agreement from the FDA (BQ200481, July 8, 2020), completion of Stage 1 was not required.
INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) and stored for 7days at 20-24°C with continuous agitation. Samples from the Test component were processed with either the BEST or the Variant 1 procedure prior to radiolabeling. The radiolabeled autologous Test and Control platelets (approximately 10-30 mL) was simultaneously administered intravenously into the subject.
|
Stage 1-BEST
n=15 participants at risk
The study was performed in two stages. Stage 1 was a randomized, 2-period crossover design. Test platelets stored for 7 days were radiolabeled based on either the BEST or Variant 1 methods (depending on the period and randomization scheme for the Test platelets) for 12 healthy subjects. The recovery and survival for Test platelets prepared with the BEST and Variant 1 methods was compared with each other and against the fresh platelet Control. With agreement from the FDA (BQ200481, July 8, 2020), completion of Stage 1 was not required.
INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) and stored for 7days at 20-24°C with continuous agitation. Samples from the Test component were processed with either the BEST or the Variant 1 procedure prior to radiolabeling. The radiolabeled autologous Test and Control platelets (approximately 10-30 mL) was simultaneously administered intravenously into the subject.
|
Stage 2-Variant 1
n=17 participants at risk
Stage 2 is a single arm design. Test platelets from 23 healthy subjects, stored for 7 days, were prepared for radiolabeling following the Variant 1 methodology. The recovery and survival for Test platelets were compared against the fresh platelet Control. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to the requirement of the 23 subjects for Stage 2. Stage 2 AEs did not include the Variant 1 subjects from Stage 1.
INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) and stored for 7 days at 20-24°C with continuous agitation. Samples from the Test component were processed with either the BEST or the Variant 1 procedure prior to radiolabeling. The radiolabeled autologous Test and Control platelets (approximately 10-30 mL) were simultaneously administered intravenously into the subject.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthraigia
|
7.7%
1/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
6.7%
1/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
5.9%
1/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
20.0%
3/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
6.7%
1/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
13.3%
2/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
6.7%
1/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Vascular disorders
Haematoma
|
0.00%
0/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
6.7%
1/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
17.6%
3/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Gastrointestinal disorders
Abdominal distention
|
7.7%
1/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
6.7%
1/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
15.4%
2/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
6.7%
1/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
47.1%
8/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
General disorders
Fatigue
|
0.00%
0/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
6.7%
1/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
General disorders
Injection site extravasation
|
7.7%
1/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
20.0%
3/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
11.8%
2/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
General disorders
Injection site haematoma
|
7.7%
1/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
General disorders
Injection site pain
|
7.7%
1/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
5.9%
1/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
General disorders
Pyrexia
|
0.00%
0/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
6.7%
1/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
General disorders
Vessel puncture site bruise
|
15.4%
2/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
6.7%
1/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Infections and infestations
Kidney Infection
|
7.7%
1/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
6.7%
1/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
7.7%
1/13 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/15 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
0.00%
0/17 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sites cannot independently publish data from their site until the combined data from all sites has been published. Cerus must review the proposed publication prior to submission to determine if it contains confidential information.
- Publication restrictions are in place
Restriction type: OTHER