Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00092976

Purpose

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.

Condition	Intervention	Phase
Hemophilia A	Drug: ReFacto	Phase IV

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Hemophilia

Drug Information available for: Factor VIII Octocog alfa Moroctocog Alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Wyeth:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	15
Study Start Date:	February 2003
Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092976

Locations

United States, California

Los Angeles, California, United States, 90007
United States, New Jersey

New Brunswick, New Jersey, United States, 08903-0019
United States, Ohio

Cincinnati, Ohio, United States, 45229
United States, Pennsylvania

Hershey, Pennsylvania, United States, 17033

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

Study ID Numbers:	3082A2-401
Study First Received:	September 28, 2004
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00092976
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Hemophilia A

Study placed in the following topic categories:

Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Blood Coagulation Disorders

Hemophilia A
Hemostatic Disorders
Factor VIII

Additional relevant MeSH terms:

Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders

ClinicalTrials.gov processed this record on January 14, 2009