Study Evaluating Inhibitor Specificity in Hemophilia A
This study has been withdrawn prior to enrollment.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
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
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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:
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
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 October 16, 2012
