ADVATE Post Authorization Safety Surveillance

This study has been completed.
Sponsor:
Collaborator:
Baxter BioScience
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00214734
First received: September 15, 2005
Last updated: April 1, 2009
Last verified: April 2009

September 15, 2005
April 1, 2009
August 2004
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Complete list of historical versions of study NCT00214734 on ClinicalTrials.gov Archive Site
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ADVATE Post Authorization Safety Surveillance
Evaluation of Safety, Efficacy, and Immunogenicity of ADVATE in Hemophilia A- An ADVATE Post-Authorization Safety Surveillance (PASS) Study

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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Hemophilia A
Drug: rAHF-PFM
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
January 2007
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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
Male
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00214734
ADVATE PASS
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Baxter Healthcare Corporation
Baxter BioScience
Study Director: Bruce Ewenstein, MD Baxter BioScience
Baxter Healthcare Corporation
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP