CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 33 enrolled
Drug / intervention
rFIXFcbiological
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/NCT02234310
NCT02234310Phase 3Completed
CompareCT.gov

An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc; BIIB029) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia B

Bioverativ, a Sanofi company·interventional·Posted Sep 9, 2014·Updated Mar 25, 2022

In Brief

A Phase 3 clinical trial evaluating rFIXFc for Hemophilia B. Completed, enrolled 33 participants across 27 sites in 11 countries.

Detailed Summary

The primary objective of the study was to evaluate the safety of recombinant coagulation factor IX Fc fusion protein (rFIXFc, BIIB029) in previously untreated patients (PUPs) with severe hemophilia B. Secondary objectives were to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes in PUPs, and to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes in PUPs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesAustralia, Denmark, France, Ireland, Italy, Netherlands, New Zealand, Poland, Sweden, United Kingdom, United States
CollaboratorsSwedish Orphan Biovitrum

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 9, 2014
Enrollment StartNov 13, 2014
Primary CompletionAug 20, 2019
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 11.8 years ago

Interventions

rFIXFcbiological

Adjustments to the dose and interval of rFIXFc was made in this study based on investigator discretion using available pharmacokinetic (PK) data, subsequent FIX trough and peak levels, level of physical activity, and bleeding pattern, in accordance with local standards of care for a prophylactic regimen. There was an option to start study dosing as episodic treatment (on-demand).