drugset / Trial / NCT01271868

Study of Recombinant Factor IX Product, IB1001, in Previously Treated Pediatric Subjects With Hemophilia B

NCT01271868 ↗

Phase 3 Terminated 9 enrolled Medexus Pharma, Inc.
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

EvaluationDrugModalityDoseRoute
Subject trenonacog alfa Protein / enzyme biologic — —

Indications