Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A

Withdrawn before enrolling · Phase 4

Conditions studied: Hemophilia A

In brief

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.

Key facts

Study ID

NCT00168051

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

0

Starts

2005-04-01

Expected to finish

2005-11-01

Last updated by the study team

2018-09-25

Who can join

Age: 18 and older, up to 64. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Study site — Washington D.C., District of Columbia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Iowa City, Iowa, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Brussels, Belgium
• Study site — Paris, France
• Study site — Berlin, Germany
• Study site — Münster, Germany
• Study site — Milan, Italy
• Study site — Amsterdam, Netherlands
• Study site — Utrecht, Netherlands
• Study site — Christchurch, New Zealand
• Study site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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