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Eligibility
for males ages up to 17 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

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

Official Title

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

Keywords

Hemophilia B prophylaxis treatment episodic treatment

Eligibility

For males ages up to 17 years

Key Inclusion Criteria:

  • Weight>=3.5 kilogram at the time of informed consent
  • Severe hemophilia B defined as <=2 IU/dl (<=2%) endogenous factor IX documented in the medical record or as tested during the Screening Period.

Key Exclusion Criteria:

  • Prior history of inhibitor as defined by the reporting laboratory.
  • Measurable inhibitor activity at the Screening Visit, measured using the Nijmegen-modified Bethesda assay
  • History of hypersensitivity reactions associated with any intravenous immunoglobulin administration
  • History of hypersensitivity reactions associated with any recombinant coagulation factor IX Fc fusion protein (rFIXFc) administration
  • Other coagulation disorders in addition to hemophilia B
  • Injection with with a FIX concentrate other than rFIXFc
  • More than 3 injections of rFIXFc prior to confirmation of eligibility

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Locations

  • Research Site not yet accepting patients
    Sacramento, California, 95817, USA
  • Research Site not yet accepting patients
    Torrance, California, 90502, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bioverativ Therapeutics Inc.
ID
NCT02234310
Phase
Phase 3
Study Type
Interventional
Last Updated
February 2017
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