drugset / Trial / NCT00666406

Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A

NCT00666406

Phase 4 Completed 9 enrolled Baxalta now part of Shire
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to compare the pharmacokinetic parameters and safety of Advate rAHF-PFM versus Recombinate rAHF in well described previously treated patients with severe hemophilia A (factor VIII level \< 1%).

Timeline

Start
2008-03-31
Primary completion
2009-02-18
Completion
2009-02-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator ADVATE Protein / enzyme biologic 50 iu/kg

Indications