CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 27 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.

Search/NCT01662531
NCT01662531Phase 3Completed
CompareCT.gov

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

CSL Behring·interventional·Posted Aug 10, 2012·Updated May 9, 2016

In Brief

A Phase 3 clinical trial evaluating rIX-FP for Hemophilia B. Completed, enrolled 27 participants across 17 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesAustralia, Austria, Canada, Czechia, France, Germany, Israel, Italy, Russia, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 10, 2012
Enrollment StartJan 1, 2013
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.9 years ago

Interventions

rIX-FPbiological

Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP)