Study Evaluating ReFacto in Hemophilia A

This study has been completed.

First Received: June 5, 2002 Last Updated: May 17, 2006 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00038909

Purpose

To identify the causative mutations in previously untreated patients with hemophilia A enrolled in the ReFacto® clinical safety and efficacy study CTN 93-R833-0XX/C9741-28, using two established hemophilia mutation testing laboratories (one in Europe and one in North America).

Condition	Intervention
Hemophilia A	Drug: BDDrFVII

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Factor VIII Mutation Testing Program in Previously Untreated Patients (PUPs) With Hemophilia A Participating in ReFacto® Study

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Hemophilia

Drug Information available for: Octocog alfa Moroctocog Alfa Factor VIII

U.S. FDA Resources

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who were or are enrolled in Study CTN 93-R833-0XX/C9741-28, and have been treated with ReFacto® during this study are eligible for participation.
The patient (or legal guardian) must be willing to give written informed consent before any study-related procedures are performed.
A blood sample will be collected from each patient for the purpose of this study and will be analyzed at one or both of the designated central laboratories.

Exclusion Criteria:

Any condition which, in the investigator's opinion, places the patient at undue risk.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038909

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

Study ID Numbers:	3082A1-302
Study First Received:	June 5, 2002
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00038909 History of Changes
Health Authority:	United States: Food and Drug Administration

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:

Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Genetic Diseases, Inborn
Coagulation Protein Disorders

Hematologic Diseases
Blood Coagulation Disorders
Hemophilia A

ClinicalTrials.gov processed this record on July 02, 2009