Study Evaluating rFIX; BeneFIX® in Hemophilia B
Phase 3
Completed
- Conditions
- Hemophilia B
- Registration Number
- NCT00093171
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
Inclusion Criteria
- Hemophilia B (FIX:C less than 2%)
- Previous treatment of at least 150 exposure days using any FIX product
- 12 years of age and older
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie rFIX's efficacy in correcting coagulation defects in Hemophilia B patients with FIX:C ≤2%?
How does BeneFIX®'s pharmacokinetic profile compare to other recombinant Factor IX therapies in previously treated Hemophilia B patients?
Which biomarkers correlate with reduced bleeding episodes in Hemophilia B PTPs receiving rFIX prophylaxis versus on-demand treatment?
What adverse events were reported in NCT00093171 and how do they align with long-term safety data for recombinant Factor IX therapies?
How does rFIX's safety and efficacy in Hemophilia B PTPs compare to emerging gene therapy approaches like valoctocogene roxaparvovec for similar patient populations?