CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 108 enrolled
Drug / intervention
rFVIIIFcbiological
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/NCT02234323
NCT02234323Phase 3Completed
CompareCT.gov

An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia A

Bioverativ, a Sanofi company·interventional·Posted Sep 9, 2014·Updated Apr 11, 2022

In Brief

A Phase 3 clinical trial evaluating rFVIIIFc for Hemophilia A. Completed, enrolled 108 participants across 71 sites in 14 countries.

Detailed Summary

The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants (PUPs) with severe hemophilia A. The secondary objectives were to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in PUPs, to evaluate rFVIIIFc consumption for the prevention and treatment of bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc for immune tolerance induction (ITI) in participants with inhibitors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesAustralia, Brazil, Canada, France, Germany, Ireland, Italy, Netherlands, New Zealand, Poland, Spain, Sweden, United Kingdom, United States
CollaboratorsSwedish Orphan Biovitrum

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 9, 2014
Enrollment StartJan 12, 2015
Primary CompletionSep 23, 2019
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 11.8 years ago

Interventions

rFVIIIFcbiological

Administered as specified in arm description