Trials / Completed
CompletedNCT01454739
Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A
An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia A
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 240 (actual)
- Sponsor
- Bioverativ Therapeutics Inc. · Industry
- Sex
- Male
- Age
- 0 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to evaluate the long-term safety of recombinant human Factor VIII Fc fusion protein (rFVIIIFc) in participants with hemophilia A. The secondary objective of the study is to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in participants with hemophilia A.
Detailed description
Participant will follow either a prophylaxis or on-demand regimen. The starting dose in this study will be determined by the clinical profile of the participant in the preceding studies A-LONG - 997HA301 (NCT01181128), pediatric study 8HA02PED (NCT01458106), 997HA307 (NCT02083965) and 997HA309 (NCT02502149).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rFVIIIFc | Administered as specified in the treatment arm. |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2017-10-01
- Completion
- 2017-10-01
- First posted
- 2011-10-19
- Last updated
- 2020-12-19
- Results posted
- 2018-11-23
Locations
78 sites across 22 countries: United States, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01454739. Inclusion in this directory is not an endorsement.