Trials / Completed
CompletedNCT01496274
A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
A Phase II/III Open-label, Multicenter, Safety and Efficacy Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- Male
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | rIX-FP | Recombinant IX-FP (rIX-FP) is a fusion protein linking coagulation factor IX with albumin, and will be administered by intravenous administration |
Timeline
- Start date
- 2012-02-01
- Primary completion
- 2014-07-01
- First posted
- 2011-12-21
- Last updated
- 2016-05-09
- Results posted
- 2016-05-09
Locations
30 sites across 10 countries: United States, Austria, Bulgaria, France, Germany, Israel, Italy, Japan, Russia, Spain
Source: ClinicalTrials.gov record NCT01496274. Inclusion in this directory is not an endorsement.