Trials / Completed
CompletedNCT01662531
A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B
A Phase III Open-label, Multicenter, Pharmacokinetic, Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Previously Treated Children With Hemophilia B
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- Male
- Age
- 11 Years
- Healthy volunteers
- Not accepted
Summary
This study will examine the pharmacokinetics, safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children who have previously received factor replacement therapy for hemophilia B.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | rIX-FP | Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2014-10-01
- First posted
- 2012-08-10
- Last updated
- 2016-05-09
- Results posted
- 2016-05-09
Locations
17 sites across 10 countries: Australia, Austria, Canada, Czechia, France, Germany, Israel, Italy, Russia, Spain
Source: ClinicalTrials.gov record NCT01662531. Inclusion in this directory is not an endorsement.