At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 63 enrolled
Drug / intervention
rIX-FPbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating rIX-FP for Hemophilia B. Completed, enrolled 63 participants across 30 sites in 10 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesAustria, Bulgaria, France, Germany, Israel, Italy, Japan, Russia, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2011
Enrollment StartFeb 2012
Primary CompletionJul 2014
TodayJul 2026
First PostedDec 21, 2011
Enrollment StartFeb 1, 2012
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 14.5 years ago
Interventions
rIX-FPbiological
Recombinant IX-FP (rIX-FP) is a fusion protein linking coagulation factor IX with albumin, and will be administered by intravenous administration