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Study of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Participants With Hemophilia B

NCT01027364 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2020-12-19

Study results available
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Summary

The primary objectives of the study were: to evaluate the safety and tolerability of rFIXFc; to evaluate the efficacy of rFIXFc in all treatment arms; to evaluate the effectiveness of prophylaxis over on-demand (episodic) therapy by comparing the annualized number of bleeding episodes between participants receiving rFIXFc on each prevention (prophylaxis) regimen and participants receiving rFIXFc on an episodic regimen. The secondary objectives of the study were: to evaluate and assess the pharmacokinetic (PK) parameter estimates of rFIXFc and rFIX (BeneFIX®) at baseline in the Sequential PK subgroup as well as rFIXFc at Week 26 (±1 week); to evaluate participants' response to treatment; to evaluate rFIXFc consumption.

Conditions

  • Severe Hemophilia B

Interventions

DRUG

Factor IX (rFIXFc)

DRUG

rFIX

Sponsors & Collaborators

  • Swedish Orphan Biovitrum

    collaborator INDUSTRY

  • Bioverativ Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Bioverativ Therapeutics Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • France
  • Germany
  • Hong Kong
  • India
  • Italy
  • Japan
  • Poland
  • Russia
  • South Africa
  • Sweden
  • United Kingdom

Study Locations

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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 NCT01027364 on ClinicalTrials.gov