drugset / Trial / NCT01335061
Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study will be to determine if a once-weekly prophylaxis regimen of BeneFIX in subjects with moderately severe to severe Hemophilia B is safe and effective.
Timeline
- Start
- 2011-09
- Primary completion
- 2014-04
- Completion
- 2014-04
Outcome
Met primary endpoint
registry On-Demand Therapy vs Prophylaxis Therapy; p <0.0001; Paired t-test NCT01335061 ↗
release “In this study, a once-weekly prophylactic regimen with BeneFIX provided a significant reduction in bleeding, which is an important goal in managing hemophilia” pfizer.com ↗
Publications
- 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.
- Tortella BJ, Carr ME, Rendo P, Korth-Bradley J, Smith LM, Kavakli K. Once-weekly prophylaxis regimen of nonacog alfa in patients with hemophilia B: an analysis of timing of bleeding event onset. Blood Coagul Fibrinolysis. 2021 Apr 1;32(3):180-185. doi: 10.1097/MBC.0000000000001012.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BeneFIX | Protein / enzyme biologic | 100 iu/kg | — |