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An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A

NCT02234323 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-04-11

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

rFVIIIFc

Administered as specified in arm description

Sponsors & Collaborators

  • Swedish Orphan Biovitrum

    collaborator INDUSTRY

  • Bioverativ, a Sanofi company

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
5 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-12
Primary Completion
2019-09-23
Completion
2019-09-23

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02234323 on ClinicalTrials.gov