Brief Title
Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B
Official Title
An Open-Label, Multicenter, Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia B
Brief Summary
The primary objective of the study is to evaluate the long-term safety of rFIXFc in participants with hemophilia B. The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes.
Detailed Description
Participants will follow either a prophylaxis or on-demand regimen. The starting dose in this study will be determined by the clinical profile of the patient in the preceding studies, B-LONG 998HB102 (NCT01027364) and Kids B-LONG study 9HB02PED (NCT01440946)
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Number of Participants With Any Positive Inhibitor Development
Secondary Outcome
Annualized Bleeding Rate (ABR)
Condition
Severe Hemophilia B
Intervention
rFIXFc
Study Arms / Comparison Groups
On-Demand
Description: The individual dose of rFIXFc to treat bleeding episodes will be based on participant's clinical condition, type and severity of the bleeding event, and if indicated, Factor IX peak (recovery) levels.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
120
Start Date
December 8, 2011
Completion Date
October 2017
Primary Completion Date
October 2017
Eligibility Criteria
Key Inclusion Criteria: - Subjects who have completed studies 998HB102 (NCT01027364) or 9HB02PED (NCT01440946) or other studies with rFIXFc - Ability to understand the purposes & risks of the study and provide signed and dated informed consent. Key Exclusion Criteria: - High-titer inhibitor (>/=5.00 BU/mL) NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Director, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT01425723
Organization ID
9HB01EXT
Secondary IDs
2011-003075-11
Responsible Party
Sponsor
Study Sponsor
Bioverativ Therapeutics Inc.
Study Sponsor
Medical Director, Study Director, Bioverativ Therapeutics Inc.
Verification Date
November 2018