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ADVATE Post Authorization Safety Surveillance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00214734
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 23, 2017
Baxter BioScience
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Brief Summary:
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 or disease Intervention/treatment
Hemophilia A Drug: rAHF-PFM

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00214734

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Sponsors and Collaborators
Baxalta now part of Shire
Baxter BioScience
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Study Director: Bruce Ewenstein, MD Baxter BioScience

Layout table for additonal information Identifier: NCT00214734    
Other Study ID Numbers: ADVATE PASS
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: April 2009
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn