An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Untreated Males With Severe Hemophilia A
Status: | Active, not recruiting |
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Conditions: | Anemia, Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | Any - 5 |
Updated: | 10/7/2018 |
Start Date: | January 2015 |
End Date: | June 2019 |
An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia A
The primary objective of the study is to evaluate the safety of rFVIIIFc (BIIB031) in
previously untreated participants with severe hemophilia A. The secondary objectives are to
evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in
previously untreated patients (PUPs), to evaluate rFVIIIFc consumption for the prevention and
treatment of bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc
for immune tolerance induction (ITI) in participants with inhibitors.
previously untreated participants with severe hemophilia A. The secondary objectives are to
evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in
previously untreated patients (PUPs), to evaluate rFVIIIFc consumption for the prevention and
treatment of bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc
for immune tolerance induction (ITI) in participants with inhibitors.
Key Inclusion Criteria:
- Ability of the participant's legally authorized representative (e.g. their parent or
legal guardian) to understand the purpose and risks of the study and provide signed
and dated informed consent and authorization to use confidential health information in
accordance with national and local subject privacy regulations.
- Weight >=3.5 kg at the time of screening.
- Severe hemophilia A defined as <1 IU/dL (<1%) endogenous FVIII documented in the
medical record or as tested during the Screening Period
Key Exclusion Criteria:
- Any exposure to blood components, factor VIII replacement products, including
commercially available rFVIIIFc at any time prior to or during screening.
- Other coagulation disorder(s) in addition to hemophilia A.
- Any concurrent clinically significant major disease that, in the opinion of the
Investigator, would make the participant unsuitable for enrollment.
- Current systemic treatment with chemotherapy and/or other immunosuppressant drugs.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
20
sites
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