Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery

Completed · Phase 4

Conditions studied: Hemophilia A

In brief

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.

Key facts

Study ID

NCT00092976

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

15

Starts

2003-02-01

Expected to finish

2007-07-01

Last updated by the study team

2007-12-28

Who can join

Age: 6 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 6 years
• Male previously treated patients (≥150 Exposure Days) with moderate or severe hemophilia A (i.e. ≤ 5% FVIII:C) who will undergo elective major surgery that is anticipated to require at least 6 consecutive days of daily factor VIII (FVIII) infusions (surgical and post-surgical prophylaxis)
• Ability to adhere to the protocol requirements

You may not qualify if…

• Hypersensitivity to ReFacto, murine allergen, or hamster allergen 2 History of FVIII inhibitor or current inhibitor, defined as > 0.6 BU
• Prior participation in this study
• Any concomitant bleeding disorder other than hemophilia A

Where it is running

• Study site — Los Angeles, California, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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