Trials / Completed
CompletedNCT01027377
Study of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A
An Open-Label, Crossover, Dose-Escalation, and Multi-Center Study to Determine the Safety, Tolerability, and Pharmacokinetic of a Single Intravenous Injection of rFVIIIFc in Previously Treated Patients With Severe Hemophilia A
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Bioverativ Therapeutics Inc. · Industry
- Sex
- Male
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The study is to investigate the safety, tolerability, and pharmacokinetics (the determination of the concentration of the administered drug in blood over time) of recombinant Factor VIII Fc fusion protein (rFVIIIFc) in previously-treated subjects with severe hemophilia A.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rFVIIIFc | Single dose |
| DRUG | rFVIIIFc | Single dose |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2010-07-01
- Completion
- 2011-05-01
- First posted
- 2009-12-07
- Last updated
- 2020-12-19
Locations
7 sites across 3 countries: United States, Hong Kong, Israel
Source: ClinicalTrials.gov record NCT01027377. Inclusion in this directory is not an endorsement.