Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• 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:

• 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

Exclusion Criteria:

• 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