Trials / Completed
CompletedNCT01757405
Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen
A PHASE 3, PROSPECTIVE, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE SAFETY AND EFFICACY OF RECOMBINANT ACTIVATED FVII BI (rFVIIa BI) IN THE TREATMENT OF ACUTE BLEEDING EPISODES PER AN ON-DEMAND REGIMEN IN PATIENTS WITH HEMOPHILIA A OR B WITH INHIBITORS
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- Male
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to determine the efficacy and safety of rFVIIa BI as part of a six-month on-demand treatment regimen in hemophilia A or B subjects with inhibitors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant Factor VIIa BI (rFVIIa BI) | Administered approximately every 3 hours as an intravenous bolus injection on-demand |
| BIOLOGICAL | Recombinant Factor VIIa BI (rFVIIa BI) | Administered as a single intravenous bolus injection on-demand |
Timeline
- Start date
- 2013-02-20
- Primary completion
- 2014-11-11
- Completion
- 2014-11-11
- First posted
- 2012-12-28
- Last updated
- 2021-05-11
- Results posted
- 2016-10-25
Locations
16 sites across 9 countries: United States, Japan, Poland, Romania, Russia, Serbia, Spain, Taiwan, Ukraine
Source: ClinicalTrials.gov record NCT01757405. Inclusion in this directory is not an endorsement.