Trial Outcomes & Findings for FEIBA Reconstitution Volume Reduction and Faster Infusion Study (FEIBA STAR) (NCT NCT02764489)
NCT ID: NCT02764489
Last Updated: 2023-02-14
Results Overview
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
45 participants
Primary outcome timeframe
From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
Results posted on
2023-02-14
Participant Flow
Participants took part in the study at 18 investigative sites in Thailand, Malaysia, Algeria, Croatia, India, Poland, Turkey, and Ukraine from 12 February 2019 to 27 December 2021. Participants with a diagnosis of Congenital Hemophilia A were enrolled.
Participants received factor eight inhibitor bypassing activity (FEIBA) reconstituted in regular volume and FEIBA reconstituted in 50% reduced volume in a crossover fashion for Part 1 and FEIBA reconstituted in 50% reduced volume at escalated infusion rates for Part 2. Participants who completed Part 1 entered Part 2 of the study. A total of 45 participants were enrolled in the study out of which 33 participants received the study treatment.
Participant milestones
| Measure |
Part 1: Sequence A-FEIBA 85±15U/kg in Regular Volume, Then FEIBA 85± 15U/kg in 50% Reduced Volume
Participants were first randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in regular volume SWFI at the standard rate of 2 U/kg/min, every 48 hours. Participants then received 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in 50% reduced volume SWFI, at the standard rate of 2 U/kg/min, every 48 hours.
|
Part 1: Sequence B-FEIBA 85±15 U/kg in 50% Reduced Volume, Then FEIBA 85±15 U/kg in Regular Volume
Participants were first randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in 50% reduced volume SWFI, at the standard rate of 2 U/kg/min, every 48 hours. Participants then received 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in regular volume SWFI at the standard rate of 2 U/kg/min, every 48 hours.
|
|---|---|---|
|
Part 1: Day 1 up to Day 16
STARTED
|
17
|
16
|
|
Part 1: Day 1 up to Day 16
COMPLETED
|
14
|
16
|
|
Part 1: Day 1 up to Day 16
NOT COMPLETED
|
3
|
0
|
|
Part 2: Day 19 up to Day 41
STARTED
|
14
|
16
|
|
Part 2: Day 19 up to Day 41
Part 2: FEIBA 85±15U/kg 50% Reduced Volume at 4U/kg/Min Rate
|
14
|
16
|
|
Part 2: Day 19 up to Day 41
Part 2: FEIBA 85±15U/kg 50% Reduced Volume at 10U/kg/Min Rate
|
12
|
16
|
|
Part 2: Day 19 up to Day 41
COMPLETED
|
12
|
16
|
|
Part 2: Day 19 up to Day 41
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Part 1: Sequence A-FEIBA 85±15U/kg in Regular Volume, Then FEIBA 85± 15U/kg in 50% Reduced Volume
Participants were first randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in regular volume SWFI at the standard rate of 2 U/kg/min, every 48 hours. Participants then received 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in 50% reduced volume SWFI, at the standard rate of 2 U/kg/min, every 48 hours.
|
Part 1: Sequence B-FEIBA 85±15 U/kg in 50% Reduced Volume, Then FEIBA 85±15 U/kg in Regular Volume
Participants were first randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in 50% reduced volume SWFI, at the standard rate of 2 U/kg/min, every 48 hours. Participants then received 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in regular volume SWFI at the standard rate of 2 U/kg/min, every 48 hours.
|
|---|---|---|
|
Part 1: Day 1 up to Day 16
Adverse Event
|
2
|
0
|
|
Part 1: Day 1 up to Day 16
Withdrawal by Subject
|
1
|
0
|
|
Part 2: Day 19 up to Day 41
Adverse Event
|
1
|
0
|
|
Part 2: Day 19 up to Day 41
Physician Decision
|
1
|
0
|
Baseline Characteristics
FEIBA Reconstitution Volume Reduction and Faster Infusion Study (FEIBA STAR)
Baseline characteristics by cohort
| Measure |
Part 1 + Part 2: Overall FEIBA Treatment
n=33 Participants
Part 1:
Participants who were eligible were randomized to receive: 3 infusions (infusions 1, 2 and 3) of FEIBA 85 ± 15 U/kg, reconstituted in regular volume SWFI followed by 3 infusions (infusions 4, 5 and 6) of FEIBA 85 ± 15 U/kg reconstituted in 50% reduced volume SWFI (Sequence A) or: 3 infusions (infusions 1, 2 and 3) of FEIBA 85 ± 15 U/kg, reconstituted in 50% reduced volume SWFI, followed by 3 infusions of FEIBA 85 ± 15 U/kg, reconstituted in regular volume SWFI (Sequence B).
All infusions in Part 1 were given at the standard infusion rate of 2 U/kg/min.
Part 2:
Participants who completed Part 1, received FEIBA 85 ± 15 U/kg, reconstituted in 50% reduced volume SWFI at an increased rate of 4 U/kg/min for infusions 7, 8, and 9, followed by FEIBA 85 ± 15 U/kg, reconstituted in 50% reduced volume SWFI at an increased rate of 10 U/kg/min for infusions 10, 11, and 12.
|
|---|---|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 11.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 7 days after the end of infusion (up to Day 41)Population: SAS included all participants who received at least one dose of IP (i.e., FEIBA).
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Part 1:FEIBA 85 ± 15 U/kg Regular Volume at 2 U/kg/Min Rate
n=33 Participants
Participants were randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in regular volume SWFI at the standard rate of 2 U/kg/min, every 48 hours (Participants in Sequence A: infusions 1, 2, and 3 and Participants in Sequence B: infusions 4, 5 and 6).
|
Part 1:FEIBA 85±15 U/kg 50% Reduced Volume at 2 U/kg/Min Rate
n=30 Participants
Participants were randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in 50% reduced volume SWFI, at the standard rate of 2 U/kg/min, every 48 hours (Participants in Sequence A: infusions 4, 5, and 6 and Participants in Sequence B: infusions 1, 2 and 3).
|
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 4 U/kg/Min Rate
n=30 Participants
Participants who completed Part 1 of the study received up to 3 infusions of FEIBA 85 ± 15 U/kg IV reconstituted in 50% reduced volume SWFI at an increased rate of 4 U/kg/min, every 48 hours (infusions 7, 8, and 9).
|
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 10 U/kg/Min Rate
n=28 Participants
Participants who completed Part 1 of the study and received up to 3 infusions (infusions 7, 8, and 9) at the rate of 4 U/kg/min in Part 2 received up to 3 infusions (10, 11, and 12) of FEIBA 85 ± 15 U/kg IV reconstituted in 50% reduced volume SWFI at an increased infusion rate of 10 U/kg/min, every 48 hours.
|
|---|---|---|---|---|
|
Number of Participants With Any Treatment Emergent Adverse Event (TEAE)
|
8 Participants
|
7 Participants
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 7 days after the end of infusion (up to Day 41)Population: SAS included all participants who received at least one dose of IP (i.e., FEIBA).
Number of participants with AEs particular to allergic-type hypersensitivity reactions were assessed. Clinical manifestations of hypersensitivity reactions included, but was not limited to skin rash, pruritus (itching), urticaria (hives), angioedema (for example, swelling of the lips and/or tongue) and anaphylactic reaction.
Outcome measures
| Measure |
Part 1:FEIBA 85 ± 15 U/kg Regular Volume at 2 U/kg/Min Rate
n=33 Participants
Participants were randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in regular volume SWFI at the standard rate of 2 U/kg/min, every 48 hours (Participants in Sequence A: infusions 1, 2, and 3 and Participants in Sequence B: infusions 4, 5 and 6).
|
Part 1:FEIBA 85±15 U/kg 50% Reduced Volume at 2 U/kg/Min Rate
n=30 Participants
Participants were randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in 50% reduced volume SWFI, at the standard rate of 2 U/kg/min, every 48 hours (Participants in Sequence A: infusions 4, 5, and 6 and Participants in Sequence B: infusions 1, 2 and 3).
|
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 4 U/kg/Min Rate
n=30 Participants
Participants who completed Part 1 of the study received up to 3 infusions of FEIBA 85 ± 15 U/kg IV reconstituted in 50% reduced volume SWFI at an increased rate of 4 U/kg/min, every 48 hours (infusions 7, 8, and 9).
|
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 10 U/kg/Min Rate
n=28 Participants
Participants who completed Part 1 of the study and received up to 3 infusions (infusions 7, 8, and 9) at the rate of 4 U/kg/min in Part 2 received up to 3 infusions (10, 11, and 12) of FEIBA 85 ± 15 U/kg IV reconstituted in 50% reduced volume SWFI at an increased infusion rate of 10 U/kg/min, every 48 hours.
|
|---|---|---|---|---|
|
Number of Participants With Any Hypersensitivity Reaction
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 7 days after the end of infusion (up to Day 41)Population: SAS included all participants who received at least one dose of IP (i.e., FEIBA).
Participants with adverse events related to thromboembolic event were reported. Clinical manifestations of thromboembolic events included, but was not limited to myocardial infarction, deep vein thrombosis, pulmonary embolism, stroke and transitory ischemic attack.
Outcome measures
| Measure |
Part 1:FEIBA 85 ± 15 U/kg Regular Volume at 2 U/kg/Min Rate
n=33 Participants
Participants were randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in regular volume SWFI at the standard rate of 2 U/kg/min, every 48 hours (Participants in Sequence A: infusions 1, 2, and 3 and Participants in Sequence B: infusions 4, 5 and 6).
|
Part 1:FEIBA 85±15 U/kg 50% Reduced Volume at 2 U/kg/Min Rate
n=30 Participants
Participants were randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in 50% reduced volume SWFI, at the standard rate of 2 U/kg/min, every 48 hours (Participants in Sequence A: infusions 4, 5, and 6 and Participants in Sequence B: infusions 1, 2 and 3).
|
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 4 U/kg/Min Rate
n=30 Participants
Participants who completed Part 1 of the study received up to 3 infusions of FEIBA 85 ± 15 U/kg IV reconstituted in 50% reduced volume SWFI at an increased rate of 4 U/kg/min, every 48 hours (infusions 7, 8, and 9).
|
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 10 U/kg/Min Rate
n=28 Participants
Participants who completed Part 1 of the study and received up to 3 infusions (infusions 7, 8, and 9) at the rate of 4 U/kg/min in Part 2 received up to 3 infusions (10, 11, and 12) of FEIBA 85 ± 15 U/kg IV reconstituted in 50% reduced volume SWFI at an increased infusion rate of 10 U/kg/min, every 48 hours.
|
|---|---|---|---|---|
|
Number of Participants With Any Thromboembolic Event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 7 days after the end of infusion (up to Day 41)Population: SAS included all participants who received at least one dose of IP (i.e., FEIBA).
Infusion sites were monitored for pain, tenderness, erythema, and swelling. Infusion site evaluations were made by clinical staff or by the participant or caregiver.
Outcome measures
| Measure |
Part 1:FEIBA 85 ± 15 U/kg Regular Volume at 2 U/kg/Min Rate
n=33 Participants
Participants were randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in regular volume SWFI at the standard rate of 2 U/kg/min, every 48 hours (Participants in Sequence A: infusions 1, 2, and 3 and Participants in Sequence B: infusions 4, 5 and 6).
|
Part 1:FEIBA 85±15 U/kg 50% Reduced Volume at 2 U/kg/Min Rate
n=30 Participants
Participants were randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in 50% reduced volume SWFI, at the standard rate of 2 U/kg/min, every 48 hours (Participants in Sequence A: infusions 4, 5, and 6 and Participants in Sequence B: infusions 1, 2 and 3).
|
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 4 U/kg/Min Rate
n=30 Participants
Participants who completed Part 1 of the study received up to 3 infusions of FEIBA 85 ± 15 U/kg IV reconstituted in 50% reduced volume SWFI at an increased rate of 4 U/kg/min, every 48 hours (infusions 7, 8, and 9).
|
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 10 U/kg/Min Rate
n=28 Participants
Participants who completed Part 1 of the study and received up to 3 infusions (infusions 7, 8, and 9) at the rate of 4 U/kg/min in Part 2 received up to 3 infusions (10, 11, and 12) of FEIBA 85 ± 15 U/kg IV reconstituted in 50% reduced volume SWFI at an increased infusion rate of 10 U/kg/min, every 48 hours.
|
|---|---|---|---|---|
|
Number of Participants With Any Infusion Site Reaction
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 7 days after the end of infusion (up to Day 41)Population: SAS included all participants who received at least one dose of IP (i.e., FEIBA).
Outcome measures
| Measure |
Part 1:FEIBA 85 ± 15 U/kg Regular Volume at 2 U/kg/Min Rate
n=33 Participants
Participants were randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in regular volume SWFI at the standard rate of 2 U/kg/min, every 48 hours (Participants in Sequence A: infusions 1, 2, and 3 and Participants in Sequence B: infusions 4, 5 and 6).
|
Part 1:FEIBA 85±15 U/kg 50% Reduced Volume at 2 U/kg/Min Rate
n=30 Participants
Participants were randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in 50% reduced volume SWFI, at the standard rate of 2 U/kg/min, every 48 hours (Participants in Sequence A: infusions 4, 5, and 6 and Participants in Sequence B: infusions 1, 2 and 3).
|
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 4 U/kg/Min Rate
n=30 Participants
Participants who completed Part 1 of the study received up to 3 infusions of FEIBA 85 ± 15 U/kg IV reconstituted in 50% reduced volume SWFI at an increased rate of 4 U/kg/min, every 48 hours (infusions 7, 8, and 9).
|
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 10 U/kg/Min Rate
n=28 Participants
Participants who completed Part 1 of the study and received up to 3 infusions (infusions 7, 8, and 9) at the rate of 4 U/kg/min in Part 2 received up to 3 infusions (10, 11, and 12) of FEIBA 85 ± 15 U/kg IV reconstituted in 50% reduced volume SWFI at an increased infusion rate of 10 U/kg/min, every 48 hours.
|
|---|---|---|---|---|
|
Number of Participants With AEs Leading to Study Discontinuation
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 7 days after the end of infusion (up to Day 41)Population: SAS included all participants who received at least one dose of IP (i.e., FEIBA).
Number of participants with vital signs considered as AEs were assessed. Vital signs included body temperature (degree Celsius or degrees Fahrenheit \[°C or °F\]), respiratory rate (breaths/min), pulse rate (beats/min), and systolic and diastolic blood pressure (millimeter of mercury \[mmHg\]).
Outcome measures
| Measure |
Part 1:FEIBA 85 ± 15 U/kg Regular Volume at 2 U/kg/Min Rate
n=33 Participants
Participants were randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in regular volume SWFI at the standard rate of 2 U/kg/min, every 48 hours (Participants in Sequence A: infusions 1, 2, and 3 and Participants in Sequence B: infusions 4, 5 and 6).
|
Part 1:FEIBA 85±15 U/kg 50% Reduced Volume at 2 U/kg/Min Rate
n=30 Participants
Participants were randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in 50% reduced volume SWFI, at the standard rate of 2 U/kg/min, every 48 hours (Participants in Sequence A: infusions 4, 5, and 6 and Participants in Sequence B: infusions 1, 2 and 3).
|
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 4 U/kg/Min Rate
n=30 Participants
Participants who completed Part 1 of the study received up to 3 infusions of FEIBA 85 ± 15 U/kg IV reconstituted in 50% reduced volume SWFI at an increased rate of 4 U/kg/min, every 48 hours (infusions 7, 8, and 9).
|
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 10 U/kg/Min Rate
n=28 Participants
Participants who completed Part 1 of the study and received up to 3 infusions (infusions 7, 8, and 9) at the rate of 4 U/kg/min in Part 2 received up to 3 infusions (10, 11, and 12) of FEIBA 85 ± 15 U/kg IV reconstituted in 50% reduced volume SWFI at an increased infusion rate of 10 U/kg/min, every 48 hours.
|
|---|---|---|---|---|
|
Number of Participants With Vital Signs Considered as AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 7 days after the end of infusion (up to Day 41)Population: SAS included all participants who received at least one dose of IP (i.e., FEIBA). Participants were counted more than once in the arm groups. Participants counted in Part 1 regular volume and in Part 1 reduced volume were the same.
Number of participants with Laboratory Assessments considered as AEs were assessed. Laboratory assessments included hematology, clinical chemistry, coagulation testing, serological testing, pregnancy testing, cluster differentiation 4 (CD4).
Outcome measures
| Measure |
Part 1:FEIBA 85 ± 15 U/kg Regular Volume at 2 U/kg/Min Rate
n=33 Participants
Participants were randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in regular volume SWFI at the standard rate of 2 U/kg/min, every 48 hours (Participants in Sequence A: infusions 1, 2, and 3 and Participants in Sequence B: infusions 4, 5 and 6).
|
Part 1:FEIBA 85±15 U/kg 50% Reduced Volume at 2 U/kg/Min Rate
n=30 Participants
Participants were randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in 50% reduced volume SWFI, at the standard rate of 2 U/kg/min, every 48 hours (Participants in Sequence A: infusions 4, 5, and 6 and Participants in Sequence B: infusions 1, 2 and 3).
|
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 4 U/kg/Min Rate
n=30 Participants
Participants who completed Part 1 of the study received up to 3 infusions of FEIBA 85 ± 15 U/kg IV reconstituted in 50% reduced volume SWFI at an increased rate of 4 U/kg/min, every 48 hours (infusions 7, 8, and 9).
|
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 10 U/kg/Min Rate
n=28 Participants
Participants who completed Part 1 of the study and received up to 3 infusions (infusions 7, 8, and 9) at the rate of 4 U/kg/min in Part 2 received up to 3 infusions (10, 11, and 12) of FEIBA 85 ± 15 U/kg IV reconstituted in 50% reduced volume SWFI at an increased infusion rate of 10 U/kg/min, every 48 hours.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Assessments Considered as AEs
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Part 1:FEIBA 85 ± 15 U/kg Regular Volume at 2 U/kg/Min Rate
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1:FEIBA 85±15 U/kg 50% Reduced Volume at 2 U/kg/Min Rate
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 4 U/kg/Min Rate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 10 U/kg/Min Rate
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1:FEIBA 85 ± 15 U/kg Regular Volume at 2 U/kg/Min Rate
n=33 participants at risk
Participants were randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in regular volume SWFI at the standard rate of 2 U/kg/min, every 48 hours (Participants in Sequence A: infusions 1, 2, and 3 and Participants in Sequence B: infusions 4, 5 and 6).
|
Part 1:FEIBA 85±15 U/kg 50% Reduced Volume at 2 U/kg/Min Rate
n=30 participants at risk
Participants were randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in 50% reduced volume SWFI, at the standard rate of 2 U/kg/min, every 48 hours (Participants in Sequence A: infusions 4, 5, and 6 and Participants in Sequence B: infusions 1, 2 and 3).
|
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 4 U/kg/Min Rate
n=30 participants at risk
Participants who completed Part 1 of the study received up to 3 infusions of FEIBA 85 ± 15 U/kg IV reconstituted in 50% reduced volume SWFI at an increased rate of 4 U/kg/min, every 48 hours (infusions 7, 8, and 9).
|
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 10 U/kg/Min Rate
n=28 participants at risk
Participants who completed Part 1 of the study and received up to 3 infusions (infusions 7, 8, and 9) at the rate of 4 U/kg/min in Part 2 received up to 3 infusions (10, 11, and 12) of FEIBA 85 ± 15 U/kg IV reconstituted in 50% reduced volume SWFI at an increased infusion rate of 10 U/kg/min, every 48 hours.
|
|---|---|---|---|---|
|
Immune system disorders
Drug hypersensitivity
|
3.0%
1/33 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
0.00%
0/30 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
0.00%
0/30 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
0.00%
0/28 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
|
Nervous system disorders
Epilepsy
|
3.0%
1/33 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
0.00%
0/30 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
0.00%
0/30 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
0.00%
0/28 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
|
Immune system disorders
Hypersensitivity
|
3.0%
1/33 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
0.00%
0/30 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
0.00%
0/30 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
0.00%
0/28 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/33 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
3.3%
1/30 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
0.00%
0/30 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
0.00%
0/28 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
Other adverse events
| Measure |
Part 1:FEIBA 85 ± 15 U/kg Regular Volume at 2 U/kg/Min Rate
n=33 participants at risk
Participants were randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in regular volume SWFI at the standard rate of 2 U/kg/min, every 48 hours (Participants in Sequence A: infusions 1, 2, and 3 and Participants in Sequence B: infusions 4, 5 and 6).
|
Part 1:FEIBA 85±15 U/kg 50% Reduced Volume at 2 U/kg/Min Rate
n=30 participants at risk
Participants were randomized to receive 3 infusions of FEIBA 85 ± 15 U/kg, IV reconstituted in 50% reduced volume SWFI, at the standard rate of 2 U/kg/min, every 48 hours (Participants in Sequence A: infusions 4, 5, and 6 and Participants in Sequence B: infusions 1, 2 and 3).
|
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 4 U/kg/Min Rate
n=30 participants at risk
Participants who completed Part 1 of the study received up to 3 infusions of FEIBA 85 ± 15 U/kg IV reconstituted in 50% reduced volume SWFI at an increased rate of 4 U/kg/min, every 48 hours (infusions 7, 8, and 9).
|
Part 2:FEIBA 85±15 U/kg 50% Reduced Volume at 10 U/kg/Min Rate
n=28 participants at risk
Participants who completed Part 1 of the study and received up to 3 infusions (infusions 7, 8, and 9) at the rate of 4 U/kg/min in Part 2 received up to 3 infusions (10, 11, and 12) of FEIBA 85 ± 15 U/kg IV reconstituted in 50% reduced volume SWFI at an increased infusion rate of 10 U/kg/min, every 48 hours.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
1/33 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
10.0%
3/30 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
0.00%
0/30 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
7.1%
2/28 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
|
Nervous system disorders
Headache
|
3.0%
1/33 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
6.7%
2/30 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
0.00%
0/30 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
0.00%
0/28 • From first dose of study drug up to 7 days after the end of infusion (up to Day 41)
At each visit investigator documented occurrence of adverse events(untoward medical occurrence in participant administered IP that does not necessarily have a causal relationship with treatment). SAS=participants receiving at least one dose of IP(FEIBA).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER