Study Evaluating rFIX; BeneFIX® in Hemophilia B
An Open-label Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX®) in Previously Treated Patients (PTPs) With Hemophilia B (FIX:C ≤2%)
1 other identifier
interventional
23
1 country
7
Brief Summary
The primary objective of this clinical research study is to assess the safety and efficacy of rFIX for a minimum of 6 months in previously treated patients (PTPs) with hemophilia B (FIX:C ≤2%) during standard-of-care treatment (on-demand, prophylaxis, and through major and minor surgical procedures).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2004
CompletedFirst Posted
Study publicly available on registry
October 7, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedAugust 21, 2009
August 1, 2009
October 4, 2004
August 20, 2009
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Hemophilia B (FIX:C less than 2%)
- Previous treatment of at least 150 exposure days using any FIX product
- years of age and older
You may not qualify if:
- The patient has a currently detectable factor IX inhibitor or a history of inhibitors. (A family history of inhibitors will not exclude the patient)
- Known hypersensitivity to protein pharmaceuticals or agents related to the test article, e.g. hamster proteins
- Patient has a genetic coagulation disorder other than hemophilia B
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Los Angeles, California, 90027, United States
Unknown Facility
Aurora, Colorado, 80262, United States
Unknown Facility
Detroit, Michigan, 48201, United States
Unknown Facility
New Brunswick, New Jersey, 08903, United States
Unknown Facility
Chapel Hill, North Carolina, 27599-7016, United States
Unknown Facility
Dayton, Ohio, 45404, United States
Unknown Facility
Houston, Texas, 77030, United States
Related Publications (2)
Wojciechowski J, Gaitonde P, Hughes JH, Ravva P. Population Modeling of Factor IX Activity Following Administration of Fidanacogene Elaparvovec Gene Therapy in Participants with Hemophilia B. Clin Pharmacokinet. 2025 Oct;64(10):1531-1548. doi: 10.1007/s40262-025-01535-y. Epub 2025 Aug 1.
PMID: 40750723DERIVEDRendo P, Smith L, Lee HY, Shafer F. Nonacog alfa: an analysis of safety data from six prospective clinical studies in different patient populations with haemophilia B treated with different therapeutic modalities. Blood Coagul Fibrinolysis. 2015 Dec;26(8):912-8. doi: 10.1097/MBC.0000000000000359.
PMID: 26196195DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor, MD
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 4, 2004
First Posted
October 7, 2004
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
August 21, 2009
Record last verified: 2009-08