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Study Evaluating Inhibitor Specificity in Hemophilia A

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NCT00151385

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Atlanta, Georgia, 30322 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

· 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients who have had an inhibitor prior to their current inhibitor.

- Patients with immune disorders.

NCT00151385
Pfizer
Withdrawn
Study Evaluating Inhibitor Specificity in Hemophilia A

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Study Evaluating Inhibitor Specificity in Hemophilia A
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.
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Hemophilia A
Procedure: single blood draw
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2007
Not Provided

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   Italy,   Spain,   United Kingdom,   United States
 
 
NCT00151385
3082A-101342
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trail Manager For Italy, [email protected]
Principal Investigator: Trial Manager For Spain, [email protected]
Principal Investigator: Trial Manager For UK, [email protected]
Principal Investigator: Trial Manager For Belgium, [email protected]
Principal Investigator: Trial Manager For Germany, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
June 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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