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.
· Patients with moderate or severe congenital hemophilia A, a current FVIII inhibitor, who
have taken at least two different FVIII products during their lifetime.
- Patients who have had an inhibitor prior to their current inhibitor.
- Patients with immune disorders.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating Inhibitor Specificity in Hemophilia A | ||||||||||||||||||
| Official Title ICMJE | 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. | ||||||||||||||||||
| Brief Summary | 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. | ||||||||||||||||||
| Detailed Description | Not Provided | ||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||
| Study Phase ICMJE | Phase 4 | ||||||||||||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Diagnostic | ||||||||||||||||||
| Condition ICMJE | Hemophilia A | ||||||||||||||||||
| Intervention ICMJE | Procedure: single blood draw | ||||||||||||||||||
| Study Arms ICMJE | Not Provided | ||||||||||||||||||
| Publications * | Not Provided | ||||||||||||||||||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||||||||||||
| Recruitment Information | |||||||||||||||||||
| Recruitment Status ICMJE | Withdrawn | ||||||||||||||||||
| Actual Enrollment ICMJE | 0 | ||||||||||||||||||
| Original Enrollment ICMJE | 18 | ||||||||||||||||||
| Actual Study Completion Date ICMJE | October 2007 | ||||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||||
| Eligibility Criteria ICMJE | 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:
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| Sex/Gender ICMJE |
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| Ages ICMJE | Child, Adult, Older Adult | ||||||||||||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||
| Listed Location Countries ICMJE | Belgium, France, Germany, Italy, Spain, United Kingdom, United States | ||||||||||||||||||
| Removed Location Countries | |||||||||||||||||||
| Administrative Information | |||||||||||||||||||
| NCT Number ICMJE | NCT00151385 | ||||||||||||||||||
| Other Study ID Numbers ICMJE | 3082A-101342 | ||||||||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||||||||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||||||||||||||
| Responsible Party | Not Provided | ||||||||||||||||||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||
| Investigators ICMJE |
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| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||||||||
| Verification Date | June 2012 | ||||||||||||||||||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||||||||||||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
