A Phase IV Study of the Safety and Efficacy of ReFacto® (Moroctocog Alfa, B-Domain Deleted Recombinant Factor VIII) in Subjects With Hemophilia A Undergoing Major Surgery Monitored Using the Chromogenic Substrate Assay at the Local Laboratory

Wyeth is now a wholly owned subsidiary of Pfizer0 sites15 target enrollmentFebruary 2003

ConditionsHemophilia A

DrugsReFacto

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Hemophilia A
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 15
Primary Endpoint: 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.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2003

End Date

July 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility 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

Outcomes

Primary Outcomes

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.