drugset / Trial / NCT01271868
Study of Recombinant Factor IX Product, IB1001, in Previously Treated Pediatric Subjects With Hemophilia B
NaSingle-groupOpen-labelTreatment
Summary
The Study's Primary Objective is to evaluate the pharmacokinetics, safety (acute effects associated with infusions, and inhibitor development) and efficacy (breakthrough bleeding and control of hemorrhaging during prophylaxis) of IB1001 in previously treated pediatric subjects with hemophilia B.
Timeline
- Start
- 2010-11
- Primary completion
- 2016-12
- Completion
- 2016-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | trenonacog alfa | Protein / enzyme biologic | — | — |