Trials / Terminated
TerminatedNCT01434511
Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Congenital Hemophilia A
Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Patients With Congenital Hemophilia A With Factor VIII Inhibitors
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
Summary
This study is to test whether the study drug (OBI-1) is safe and effective for the treatment of serious bleeding episodes in people with congenital hemophilia A.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | OBI-1 | intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment |
Timeline
- Start date
- 2011-10-03
- Primary completion
- 2013-07-29
- Completion
- 2013-07-29
- First posted
- 2011-09-15
- Last updated
- 2021-05-14
- Results posted
- 2014-12-17
Locations
3 sites across 3 countries: United States, South Africa, United Kingdom
Source: ClinicalTrials.gov record NCT01434511. Inclusion in this directory is not an endorsement.