Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery

Phase 4

Completed

• Conditions: Hemophilia A

• Registration Number: NCT00092976
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 Description

Not available

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2004-09-28
• Study First Submitted QC: 2004-09-28
• Study First Posted: 2004-09-29
• Status Verified: 2006-05
• Study Completion: 2007-07
• Last Update Submitted: 2007-12-19
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
To compare FVIII:C levels determined using the one-stage and the chromogenic substrate assays at a central laboratory