Study Evaluating Refacto for Pharmacovigilance - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00195442

Purpose

The purpose of this study is to investigate the effectiveness and safety of treatment with Refacto under conditions of routine therapy. Furthermore a continuous benefit/risk assessment will be done.

Condition	Intervention
Hemophilia A	Drug: Refacto

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Hemophilia

Drug Information available for: Factor VIII Octocog alfa

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Pharmacovigilance Evaluation of Refacto

Further study details as provided by Wyeth:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	300
Study Start Date:	July 1999
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Intervention Details:

The open-label, standard of care treatment will be dosed at a strength and frequency according to the discretion of the treating physician, using the guidance provided in the Summary of Product Characteristics (SPC). http://www.emea.europa.eu/humandocs/Humans/EPAR/refacto/refacto.htm Dosage and duration of treatment depend on the severity of the Factor VIII deficiency, the location and extent of the bleeding, and the patient's clinical condition. Doses administered should be titrated to the patient's clinical response.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

primary care clinic and community sample

Criteria

Inclusion Criteria:

Proven diagnosis of Hemophilia A

Exclusion Criteria:

Contraindications according to SmPC

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195442

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Germany, Nordrhein-Westfalen
	Recruiting
Muenster, Nordrhein-Westfalen, Germany, 48143

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial manager	For Germany, MedInfoDEU@wyeth.com

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3082A-100690
Study First Received:	September 13, 2005
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00195442
Health Authority:	Germany: Paul-Ehrlich-Institut

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
Coagulants
Coagulation Protein Disorders

Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009