Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A

• Status: Withdrawn
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate, using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Factor VIII

Criteria

Inclusion Criteria:

• Severe hemophilia A

• Previously treated patients with at least 150 exposure days to any Factor VIII product

Exclusion Criteria:

• Hypersensitivity to any recombinant Factor VIII product

• History of or current Factor VIII inhibitor

• Bleeding episode or other reason requiring Factor VIII treatment within 3 days of study