Study Evaluating ReFacto AF in Severe Hemophilia A

This study has been completed.

First Received: May 17, 2002 Last Updated: April 18, 2008 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00037544

Purpose

To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.

Condition	Intervention	Phase
Hemophilia A	Drug: ReFacto AF	Phase III

Study Type:	Interventional
Study Design:	Treatment
Official Title:	An Open-Label Study to Characterize the Safety and Efficacy of BDDrFVIII Manufactured by the Albumin Free Process (ReFacto AF) in the Treatment of Previously Treated Patients (PTP) With Severe Hemophilia A

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

Further study details as provided by Wyeth:

Study Completion Date:	August 2004
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory)
Previously treated patients with greater than or equal to 250 exposure days to any Factor VIII product
Age greater than or equal to 12 years
History of prophylaxis dosing at least twice per week on any Factor VIII product for at least 3 consecutive months within the 2 years prior to study enrollment unless the patient completed the previous pharmacokinetic study
Adequate laboratory results

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037544

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

Study ID Numbers:	3082B1-306
Study First Received:	May 17, 2002
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00037544 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Severe
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:

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

Therapeutic Uses
Blood Coagulation Disorders
Hematologic Agents
Hemophilia A
Pharmacologic Actions
Factor VIII

ClinicalTrials.gov processed this record on July 02, 2009