Clinical Trial: Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase IV Study of the Safety and Efficacy of ReFacto® (Moroctocog Alfa, B-Domain Deleted Recombinant Factor VIII) in Subjects With Hemophilia

Brief Summary: The primary objective of this clinical research study is to evaluate the safety and efficacy of ReFacto in subjects with hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.

Detailed Summary:
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Current Primary Outcome: To evaluate the safety and efficacy of ReFacto in subjects with Hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.

Original Primary Outcome:

Current Secondary Outcome: To compare FVIII:C levels determined using the one-stage and the chromogenic substrate assays at a central laboratory

Original Secondary Outcome:

Information By: Wyeth is now a wholly owned subsidiary of Pfizer

Dates:
Date Received: September 28, 2004
Date Started: February 2003
Date Completion:
Last Updated: December 19, 2007
Last Verified: May 2006