Trial Outcomes & Findings for A Safety, Tolerability, and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein (rFVIIIFc-VWF-XTEN) (BIVV001) in Previously Treated Adults With Severe Hemophilia A (EXTEN-A) (NCT NCT03205163)
NCT ID: NCT03205163
Last Updated: 2022-04-19
Results Overview
AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAE is defined as any AE that begins on or after the single dose of Advate but before the single dose of BIVV001. Serious AE (SAE) was defined as any AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anomaly/birth defect, or any other medically important event.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Up to Day 3 for Advate 25 IU/kg; up to Day 4 for Advate 65 IU/kg
Results posted on
2022-04-19
Participant Flow
The study was conducted in Japan and United States between 28 August 2017 to 12 November 2018.
A total of 16 participants were enrolled, 7 participants to low dose cohort (LDC) and 9 to high dose cohort (HDC).
Participant milestones
| Measure |
Low Dose Cohort (LDC): Advate 25 IU/kg Then BIVV001 25 IU/kg
Participants received a single intravenous (IV) dose of Advate 25 International Units per kilogram (IU/kg) on Day 1 of Advate treatment period (ATP) (3 days) followed by a single IV dose of BIVV001 25 IU/kg in BIVV001 treatment period (BTP) (28 days). ATP consisted of a washout of at least 72 hours which was started from the time of Advate dosing.
|
High Dose Cohort (HDC): Advate 65 IU/kg Then BIVV001 65 IU/kg
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days) followed by a single IV dose of BIVV001 65 IU/kg in BTP (28 days). ATP consisted of a washout of at least 96 hours which was started from the time of Advate dosing.
|
|---|---|---|
|
ATP (LDC: 3 Days; HDC: 4 Days)
STARTED
|
7
|
9
|
|
ATP (LDC: 3 Days; HDC: 4 Days)
Safety Population
|
7
|
9
|
|
ATP (LDC: 3 Days; HDC: 4 Days)
COMPLETED
|
6
|
9
|
|
ATP (LDC: 3 Days; HDC: 4 Days)
NOT COMPLETED
|
1
|
0
|
|
BTP (LDC: 28 Days; HDC: 28 Days)
STARTED
|
6
|
9
|
|
BTP (LDC: 28 Days; HDC: 28 Days)
Safety Population
|
6
|
9
|
|
BTP (LDC: 28 Days; HDC: 28 Days)
COMPLETED
|
6
|
9
|
|
BTP (LDC: 28 Days; HDC: 28 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Low Dose Cohort (LDC): Advate 25 IU/kg Then BIVV001 25 IU/kg
Participants received a single intravenous (IV) dose of Advate 25 International Units per kilogram (IU/kg) on Day 1 of Advate treatment period (ATP) (3 days) followed by a single IV dose of BIVV001 25 IU/kg in BIVV001 treatment period (BTP) (28 days). ATP consisted of a washout of at least 72 hours which was started from the time of Advate dosing.
|
High Dose Cohort (HDC): Advate 65 IU/kg Then BIVV001 65 IU/kg
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days) followed by a single IV dose of BIVV001 65 IU/kg in BTP (28 days). ATP consisted of a washout of at least 96 hours which was started from the time of Advate dosing.
|
|---|---|---|
|
ATP (LDC: 3 Days; HDC: 4 Days)
Sponsor Decision
|
1
|
0
|
Baseline Characteristics
A Safety, Tolerability, and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein (rFVIIIFc-VWF-XTEN) (BIVV001) in Previously Treated Adults With Severe Hemophilia A (EXTEN-A)
Baseline characteristics by cohort
| Measure |
LDC: Advate 25 IU/kg Then BIVV001 25 IU/kg
n=7 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days) followed by a single IV dose of BIVV001 25 IU/kg in BTP (28 days). ATP consisted of a washout of at least 72 hours which was started from the time of Advate dosing.
|
HDC: Advate 65 IU/kg Then BIVV001 65 IU/kg
n=9 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days) followed by a single IV dose of BIVV001 65 IU/kg in BTP (28 days). ATP consisted of a washout of at least 96 hours which was started from the time of Advate dosing.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.0 years
STANDARD_DEVIATION 13.81 • n=5 Participants
|
44.0 years
STANDARD_DEVIATION 11.65 • n=7 Participants
|
39.2 years
STANDARD_DEVIATION 13.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
PRIMARY outcome
Timeframe: Up to Day 3 for Advate 25 IU/kg; up to Day 4 for Advate 65 IU/kgPopulation: Analysis was performed on safety analysis set which included all participants who received at least 1 dose of Advate.
AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAE is defined as any AE that begins on or after the single dose of Advate but before the single dose of BIVV001. Serious AE (SAE) was defined as any AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anomaly/birth defect, or any other medically important event.
Outcome measures
| Measure |
Advate 25 IU/kg
n=7 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=9 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) During Advate Treatment Period
TEAE
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) During Advate Treatment Period
TESAE
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days after BIVV001 administrationPopulation: Analysis was performed on safety analysis set which included all participants who received at least 1 dose of BIVV001.
AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAE is defined as any AE that begins on or after the study treatment (BIVV001) and within 28 days after BIVV001 administration. SAE was defined as any AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anomaly/birth defect, or any other medically important event.
Outcome measures
| Measure |
Advate 25 IU/kg
n=6 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=9 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) During BIVV001 Treatment Period
TEAE
|
3 Participants
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) During BIVV001 Treatment Period
TESAE
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 3 for Advate 25 IU/kg; up to Day 4 for Advate 65 IU/kgPopulation: Analysis was performed on safety analysis set.
Number of Participants with Clinically Significant Abnormalities in Laboratory tests (including hematology, clinical chemistry, urinalysis, and coagulation and thrombosis markers) was reported.
Outcome measures
| Measure |
Advate 25 IU/kg
n=7 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=9 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Laboratory Tests During Advate Treatment Period
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days after BIVV001 administrationPopulation: Analysis was performed on safety analysis set.
Number of participants with clinically significant abnormalities (including hematology, clinical chemistry, urinalysis, and coagulation and thrombosis markers) was reported.
Outcome measures
| Measure |
Advate 25 IU/kg
n=6 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=9 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Laboratory Tests During BIVV001 Treatment Period
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days after BIVV001 administrationPopulation: Analysis was performed on safety analysis set.
Development of an inhibitor was defined as a neutralizing antibody value of greater than or equal to (\>=) 0.6 Bethesda units per milliliter (BU/mL) identified and confirmed by a second test on an independent sample, collected within 2 to 4 weeks of the first positive sample, with both tests performed by the central laboratory using Nijmegen-modified Bethesda assay.
Outcome measures
| Measure |
Advate 25 IU/kg
n=7 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=9 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
Percentage of Participants With Confirmed Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, and 240 hoursPopulation: Analysis was performed on pharmacokinetic analysis set (PKAS) which included participants who had adequate blood sample collections (following Advate or BIVV001 administration), to assess key PK parameters, as determined by the PK scientist.
Cmax of Advate and BIVV001 at low dose was assessed and compared based on One-stage activated partial thromboplastin time (aPTT)-based clotting assay.
Outcome measures
| Measure |
Advate 25 IU/kg
n=7 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=6 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) for Advate and BIVV001 (Low Dose Comparison)
|
51.8 International unit/deciliter (IU/dL)
Interval 43.3 to 61.9
|
70.1 International unit/deciliter (IU/dL)
Interval 49.7 to 98.9
|
SECONDARY outcome
Timeframe: For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, 240, 288, and 336 hoursPopulation: Analysis was performed on PKAS.
Cmax of Advate and BIVV001 at high dose was assessed and compared based on One-stage aPTT-based clotting assay.
Outcome measures
| Measure |
Advate 25 IU/kg
n=9 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=8 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
PK: Maximum Observed Plasma Concentration (Cmax) for Advate and BIVV001 (High Dose Comparison)
|
138 IU/dL
Interval 117.0 to 162.0
|
161 IU/dL
Interval 142.0 to 183.0
|
SECONDARY outcome
Timeframe: For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, and 240 hoursPopulation: Analysis was performed on PKAS.
Half-life is defined as time required for the concentration of the drug to reach half of its original value. t1/2 of Advate and BIVV001 at low dose was assessed and compared based on One-stage aPTT-based clotting assay.
Outcome measures
| Measure |
Advate 25 IU/kg
n=7 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=6 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
PK: Half-Life (t1/2) for Advate and BIVV001 (Low Dose Comparison)
|
9.12 hours
Interval 6.24 to 13.33
|
37.61 hours
Interval 33.28 to 42.5
|
SECONDARY outcome
Timeframe: For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, 240, 288, and 336 hoursPopulation: Analysis was performed on PKAS.
Half-life is defined as time required for the concentration of the drug to reach half of its original value. t1/2 of Advate and BIVV001 at high dose was assessed and compared based on One-stage aPTT-based clotting assay.
Outcome measures
| Measure |
Advate 25 IU/kg
n=9 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=8 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
PK: Half-Life for Advate and BIVV001 (High Dose Comparison)
|
13.15 hours
Interval 10.89 to 15.87
|
42.54 hours
Interval 39.72 to 45.56
|
SECONDARY outcome
Timeframe: For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, and 240 hoursPopulation: Analysis was performed on PKAS.
Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL of Advate and BIVV001 at low dose was assessed and compared based on One-stage aPTT-based clotting assay.
Outcome measures
| Measure |
Advate 25 IU/kg
n=7 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=6 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
PK: Total Body Clearance (CL) for Advate and BIVV001 (Low Dose Comparison)
|
3.91 milliliter/hour/kilogram (mL/hr/kg)
Interval 3.05 to 5.02
|
0.558 milliliter/hour/kilogram (mL/hr/kg)
Interval 0.411 to 0.757
|
SECONDARY outcome
Timeframe: For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, 240, 288, and 336 hoursPopulation: Analysis was performed on PKAS.
Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL of Advate and BIVV001 at high dose was assessed and compared based on One-stage aPTT-based clotting assay.
Outcome measures
| Measure |
Advate 25 IU/kg
n=9 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=8 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
PK: Total Body Clearance (CL) for Advate and BIVV001 (High Dose Comparison)
|
3.31 mL/hr/kg
Interval 2.81 to 3.88
|
0.505 mL/hr/kg
Interval 0.436 to 0.586
|
SECONDARY outcome
Timeframe: For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, and 240 hoursPopulation: Analysis was performed on PKAS.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss of Advate and BIVV001 at low dose was assessed and compared based on One-stage aPTT-based clotting assay.
Outcome measures
| Measure |
Advate 25 IU/kg
n=7 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=6 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
PK: Volume of Distribution at Steady State (Vss) for Advate and BIVV001 (Low Dose Comparison)
|
55.9 milliliter/kilogram (mL/kg)
Interval 51.2 to 61.0
|
34.8 milliliter/kilogram (mL/kg)
Interval 27.3 to 44.3
|
SECONDARY outcome
Timeframe: For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, 240, 288, and 336 hoursPopulation: Analysis was performed on PKAS.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss of Advate and BIVV001 at high dose was assessed and compared based on One-stage aPTT-based clotting assay.
Outcome measures
| Measure |
Advate 25 IU/kg
n=9 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=8 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
PK: Volume of Distribution at Steady State (Vss) for Advate and BIVV001 (High Dose Comparison)
|
58.3 mL/kg
Interval 49.8 to 68.2
|
35.0 mL/kg
Interval 29.7 to 41.1
|
SECONDARY outcome
Timeframe: For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, and 240 hoursPopulation: Analysis was performed on PKAS.
AUCinfinity of Advate and BIVV001 at low dose was assessed and compared based on One-stage aPTT-based clotting assay.
Outcome measures
| Measure |
Advate 25 IU/kg
n=7 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=6 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
PK: Area Under the Concentration Time Curve (AUC) From Time 0 to Infinity (AUCinfinity) for Advate and BIVV001 (Low Dose Comparison)
|
638 hour*international unit/deciliter
Interval 495.0 to 822.0
|
4470 hour*international unit/deciliter
Interval 3280.0 to 6080.0
|
SECONDARY outcome
Timeframe: For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, 240, 288, and 336 hoursPopulation: Analysis was performed on PKAS.
AUCinfinity of Advate and BIVV001 at high dose was assessed and compared based on One-stage aPTT-based clotting assay.
Outcome measures
| Measure |
Advate 25 IU/kg
n=9 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=8 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
PK: Area Under the Concentration Time Curve From Time 0 to Infinity (AUCinfinity) for Advate and BIVV001 (High Dose Comparison)
|
1960 hour*international unit/deciliter
Interval 1670.0 to 2310.0
|
12800 hour*international unit/deciliter
Interval 11100.0 to 14900.0
|
SECONDARY outcome
Timeframe: For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, and 240 hoursPopulation: Analysis was performed on PKAS.
The average time at which the number of absorbed molecules reside in the body, after single-dose administration. MRT of Advate and BIVV001 at low dose was assessed and compared based on One-stage aPTT-based clotting assay.
Outcome measures
| Measure |
Advate 25 IU/kg
n=7 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=6 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
PK: Mean Residence Time (MRT) for Advate and BIVV001 (Low Dose Comparison)
|
12.54 hours
Interval 9.82 to 16.01
|
56.93 hours
Interval 49.19 to 65.89
|
SECONDARY outcome
Timeframe: For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, 240, 288, and 336 hoursPopulation: Analysis was performed on PKAS.
The average time at which the number of absorbed molecules reside in the body, after single-dose administration. MRT of Advate and BIVV001 at high dose was assessed and compared based on One-stage aPTT-based clotting assay.
Outcome measures
| Measure |
Advate 25 IU/kg
n=9 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=8 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
PK: Mean Residence Time (MRT) for Advate and BIVV001 (High Dose Comparison)
|
15.66 hours
Interval 14.06 to 17.45
|
67.66 hours
Interval 62.59 to 73.14
|
SECONDARY outcome
Timeframe: For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, and 240 hoursPopulation: Analysis was performed on PKAS.
Incremental Recovery is defined as the increase in the circulating FVIII activity level for one unit (IU) of the FVIII product per kilogram body weight. IR of Advate and BIVV001 at low dose was assessed and compared based on One-stage aPTT-based clotting assay.
Outcome measures
| Measure |
Advate 25 IU/kg
n=7 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=6 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
PK: Incremental Recovery (IR) for Advate and BIVV001 (Low Dose Comparison)
|
2.0 IU/dL per IU/kg
Interval 1.6 to 2.5
|
2.72 IU/dL per IU/kg
Interval 1.95 to 3.8
|
SECONDARY outcome
Timeframe: For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, 240, 288, and 336 hoursPopulation: Analysis was performed on PKAS.
Incremental Recovery is defined as the increase in the circulating FVIII activity level for one unit (IU) of the FVIII product per kilogram body weight. IR of Advate and BIVV001 at high dose was assessed and compared based on One-stage aPTT-based clotting assay.
Outcome measures
| Measure |
Advate 25 IU/kg
n=9 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=8 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
PK: Incremental Recovery (IR) for Advate and BIVV001 (High Dose Comparison)
|
2.11 IU/dL per IU/kg
Interval 1.79 to 2.49
|
2.48 IU/dL per IU/kg
Interval 2.18 to 2.82
|
SECONDARY outcome
Timeframe: For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, and 240 hoursPopulation: Analysis was performed on PKAS.
Time to 1% activity is the time required from the start of dosing for the FVIII activity to reach 1 IU/dL (1%) above their baseline levels. Time to 1% above baseline for FVIII Activity of Advate and BIVV001 at low dose was assessed and compared based on One-stage aPTT-based clotting assay.
Outcome measures
| Measure |
Advate 25 IU/kg
n=7 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=6 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
PK: Time to 1% Above Baseline for FVIII Activity for Advate and BIVV001 (Low Dose Comparison)
|
56.97 hours
Interval 49.25 to 65.89
|
260.53 hours
Interval 222.34 to 305.3
|
SECONDARY outcome
Timeframe: For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, 240, 288, and 336 hoursPopulation: Analysis was performed on PKAS.
Time to 1% activity is the time required from the start of dosing for the FVIII activity to reach 1 IU/dL (1%) above their baseline levels. Time to 1% above baseline for FVIII Activity of Advate and BIVV001 at high dose was assessed and compared based on One-stage aPTT-based clotting assay.
Outcome measures
| Measure |
Advate 25 IU/kg
n=9 Participants
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate 65 IU/kg
n=8 Participants
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
|---|---|---|
|
PK: Time to 1% Above Baseline for FVIII Activity for Advate and BIVV001 (High Dose Comparison)
|
78.48 hours
Interval 70.88 to 86.89
|
350.34 hours
Interval 326.61 to 375.81
|
Adverse Events
Advate Dose Level: 25 IU/kg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Advate Dose Level: 65 IU/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BIVV001 Dose Level: 25 IU/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
BIVV001 Dose Level: 65 IU/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Advate Dose Level: 25 IU/kg
n=7 participants at risk
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate Dose Level: 65 IU/kg
n=9 participants at risk
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
BIVV001 Dose Level: 25 IU/kg
n=6 participants at risk
Participants received a single IV dose of BIVV001 25 IU/kg on Day 1 in BTP (28 days).
|
BIVV001 Dose Level: 65 IU/kg
n=9 participants at risk
Participants received a single IV dose of BIVV001 65 IU/kg on Day 1 in BTP (28 days).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
16.7%
1/6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Contusion
|
14.3%
1/7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
14.3%
1/7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
14.3%
1/7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
14.3%
1/7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
Other adverse events
| Measure |
Advate Dose Level: 25 IU/kg
n=7 participants at risk
Participants received a single IV dose of Advate 25 IU/kg on Day 1 of ATP (3 days).
|
Advate Dose Level: 65 IU/kg
n=9 participants at risk
Participants received a single IV dose of Advate 65 IU/kg on Day 1 of ATP (4 days).
|
BIVV001 Dose Level: 25 IU/kg
n=6 participants at risk
Participants received a single IV dose of BIVV001 25 IU/kg on Day 1 in BTP (28 days).
|
BIVV001 Dose Level: 65 IU/kg
n=9 participants at risk
Participants received a single IV dose of BIVV001 65 IU/kg on Day 1 in BTP (28 days).
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
16.7%
1/6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
11.1%
1/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
11.1%
1/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
16.7%
1/6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
16.7%
1/6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
11.1%
1/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
11.1%
1/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
11.1%
1/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
11.1%
1/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
|
Investigations
Coagulation test abnormal
|
14.3%
1/7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
|
Investigations
Fibrin d dimer increased
|
0.00%
0/7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
11.1%
1/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
11.1%
1/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
|
Investigations
Thrombin-antithrombin iii complex increased
|
14.3%
1/7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
11.1%
1/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
16.7%
1/6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
11.1%
1/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
11.1%
1/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
16.7%
1/6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
0.00%
0/9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (28 days after BIVV001 administration) regardless of seriousness or relationship to investigational product.
Analysis was performed on safety analysis set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER