ADVATE Post Authorization Safety Surveillance

This study has been completed.

Sponsors and Collaborators:	Baxter Healthcare Corporation Baxter BioScience
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00214734

Purpose

The primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in routine clinical practice.

Condition	Intervention
Hemophilia A	Drug: rAHF-PFM

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:	Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:	Evaluation of Safety, Efficacy, and Immunogenicity of ADVATE in Hemophilia A– An ADVATE Post-Authorization Safety Surveillance (PASS) Study

Further study details as provided by Baxter Healthcare Corporation:

Estimated Enrollment:	450
Study Start Date:	August 2004
Estimated Study Completion Date:	January 2007

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has moderate or severe hemophilia A (baseline FVIII less than or equal to 5%)
Subject currently has no measurable FVIII inhibitor titer greater than or equal to 1 BU (Bethesda or Nijmegen method)
Subject has been prescribed ADVATE by their treating physician
Subject may be of any age
Subject or parent/legally authorized representative has provided written informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214734

Show 37 Study Locations

Sponsors and Collaborators

Baxter Healthcare Corporation

Baxter BioScience

Investigators

Study Director:

Bruce Ewenstein, MD

Baxter BioScience

More Information

Study ID Numbers:	ADVATE PASS
Study First Received:	September 15, 2005
Last Updated:	May 9, 2007
ClinicalTrials.gov Identifier:	NCT00214734
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:

Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders

ClinicalTrials.gov processed this record on January 14, 2009