drugset

drugset / Trial / NCT00157105

Safety and Efficacy Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients Undergoing Surgery

NCT00157105 ↗

Phase 2/3 Completed 59 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 hemophilia A patients undergoing surgery.

Timeline

Start: 2001-02-12
Primary completion: 2004-08-03
Completion: 2004-08-03

Publications

Shapiro A, Gruppo R, Pabinger I, Collins PW, Hay CR, Schroth P, Casey K, Patrone L, Ehrlich H, Ewenstein BM. Integrated analysis of safety and efficacy of a plasma- and albumin-free recombinant factor VIII (rAHF-PFM) from six clinical studies in patients with hemophilia A. Expert Opin Biol Ther. 2009 Mar;9(3):273-83. doi: 10.1517/14712590902729392.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	rAHF-PFM	Protein / enzyme biologic	—	—

Indications