drugset / Trial / NCT00189982

Efficacy and Safety Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients in Canada With Hemophilia A - A Continuation of Baxter Study 060101

NCT00189982 ↗

Phase 2/3 Completed 4 enrolled Baxalta now part of Shire
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of children with hemophilia A. The study is open to pediatric patients in Canada who completed Baxter Study 060101.

Timeline

Start
2004-12-17
Primary completion
2006-11-10
Completion
2006-11-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant Antihemophilic Factor Unknown 25 iu/kg —
Subject Recombinant Antihemophilic Factor Unknown 50 iu/kg —

Indications