Brief Title
Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery
Official Title
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
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
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
To compare FVIII:C levels determined using the one-stage and the chromogenic substrate assays at a central laboratory
Condition
Hemophilia A
Intervention
ReFacto
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
15
Start Date
February 2003
Completion Date
July 2007
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
Gender
Male
Ages
6 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00092976
Organization ID
3082A2-401
Study Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor
Medical Monitor, MD, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date
May 2006