CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
rFIXFc +1 moredrug
Likely dose
FIX 250 IUfrom 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/NCT01440946
NCT01440946Phase 3Completed
CompareCT.gov

An Open-label, Multicenter Evaluation of Safety, Pharmacokinetics and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in the Prevention and Treatment of Bleeding Episodes in Pediatric Subjects With Hemophilia B

Bioverativ Therapeutics Inc.·interventional·Posted Sep 27, 2011·Updated Dec 19, 2020

In Brief

A Phase 3 clinical trial evaluating rFIXFc and FIX for Hemophilia B. Completed, enrolled 30 participants across 15 sites in 6 countries.

Detailed Summary

The primary objective of the study is to evaluate the safety of Recombinant Human Coagulation Factor IX Fc Fusion Protein (rFIXFc) in previously treated pediatric subjects with hemophilia B. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFIXFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFIXFc; to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesAustralia, Ireland, Netherlands, South Africa, United Kingdom, United States
CollaboratorsSwedish Orphan Biovitrum

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 27, 2011
Enrollment StartJun 1, 2012
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 14.8 years ago

Interventions

rFIXFcdrug

Vials of rFIXFc were combined as needed, based on the actual labeled potency to achieve the participant's calculated dose. Partial vial use was allowed, in order to achieve the calculated dose.

FIXdrug

Vials of prestudy FIX (provided by the participants) were combined as needed, based on the nominal labeled potency (e.g., 250 IU, 500 IU, and 1000 IU), to achieve the participant's calculated dose.