ADVATE Post Authorization Safety Surveillance

This study has been completed.
Baxter BioScience
Information provided by:
Baxalta US Inc. Identifier:
First received: September 15, 2005
Last updated: June 26, 2015
Last verified: April 2009
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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Safety, Efficacy, and Immunogenicity of ADVATE in Hemophilia A- An ADVATE Post-authorization Safety Surveillance (PASS) Study

Resource links provided by NLM:

Further study details as provided by Baxalta US Inc.:

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

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00214734

  Show 37 Study Locations
Sponsors and Collaborators
Baxalta US Inc.
Baxter BioScience
Study Director: Bruce Ewenstein, MD Baxter BioScience
  More Information Identifier: NCT00214734     History of Changes
Other Study ID Numbers: ADVATE PASS 
Study First Received: September 15, 2005
Last Updated: June 26, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders processed this record on May 26, 2016