Study Evaluating Inhibitor Specificity in Hemophilia A

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00151385
First received: September 6, 2005
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

This investigation will utilize a systematic determination of anti-FVIII antibody specificity in PTPs (> 50 ED) with hemophilia A who have developed inhibitors in response to treatment with any FVIII product(s). A group of patients with hemophilia A, who have no evidence of current or prior FVIII inhibitor will be included for comparison. The objective of this study is to describe the patterns of antibodies and associated epitopes in the study population.


Condition Intervention Phase
Hemophilia A
Procedure: single blood draw
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Multicenter Study to Describe the Immunogenic Epitope(s) of Factor VIII in Previously Treated Patients With Congenital Hemophilia A Who Develop De Novo Factor VIII Inhibitors While Receiving Factor VIII Infusion Therapy.

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Description of the patterns of antibodies and associated epitopes in a subset of
  • previously treated patients with hemophilia A.

Enrollment: 0
Study Start Date: November 2005
Study Completion Date: October 2007
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

· Patients with moderate or severe congenital hemophilia A, a current FVIII inhibitor, who have taken at least two different FVIII products during their lifetime.

Exclusion Criteria:

  • Patients who have had an inhibitor prior to their current inhibitor.
  • Patients with immune disorders.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151385

Locations
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Michigan
Detroit, Michigan, United States, 48201
United States, New York
New Hyde Park, New York, United States, 11040
New York, New York, United States, 10021
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19134
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78207
Belgium
Brussels, Belgium, 1200
Leuven, Belgium, 3000
France
La BOUEXIERE, France, 35340
Le Kremlin-Bicetre, France, 94275
Lyon, France, 69003
Germany
Berlin, Germany, 10249
Bonn, Germany, 53105
Bremen, Germany, D-28205
Muenster, Germany, 48103
Munchen, Germany, 81336
Italy
Firenze, Italy, 50134
Milano, Italy, 20122
Spain
Madrid, Spain, 28046
Valencia, Spain, 46009
United Kingdom
London, United Kingdom, E1 1BB
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trail Manager For Italy, decresg@wyeth.com
Principal Investigator: Trial Manager For Spain, MedInfoNord@wyeth.com
Principal Investigator: Trial Manager For UK, ukmedinfo@wyeth.com
Principal Investigator: Trial Manager For Belgium, trials-BEL@wyeth.com
Principal Investigator: Trial Manager For Germany, MedInfoDEU@wyeth.com
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00151385     History of Changes
Other Study ID Numbers: 3082A-101342
Study First Received: September 6, 2005
Last Updated: June 26, 2012
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014