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ADVATE Post Authorization Safety Surveillance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00214734
First Posted: September 22, 2005
Last Update Posted: October 23, 2017
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.
Collaborator:
Baxter BioScience
Information provided by:
Shire
  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

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 Shire:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): NCT00214734


  Show 37 Study Locations
Sponsors and Collaborators
Baxalta now part of Shire
Baxter BioScience
Investigators
Study Director: Bruce Ewenstein, MD Baxter BioScience
  More Information

ClinicalTrials.gov Identifier: NCT00214734     History of Changes
Other Study ID Numbers: ADVATE PASS
First Submitted: September 15, 2005
First Posted: September 22, 2005
Last Update Posted: October 23, 2017
Last Verified: April 2009

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn