Clinical trial NCT00151385: Study Evaluating Inhibitor Specificity in Hemophilia A
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hemophilia A
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: Description of the patterns of antibodies and associated epitopes in a subset of
measure: previously treated patients with hemophilia A.
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
state: Georgia
city: Detroit
country: United States
state: Michigan
city: New Hyde Park
country: United States
state: New York
city: New York
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Brussels
country: Belgium
city: Leuven
country: Belgium
city: La BOUEXIERE
country: France
city: Le Kremlin-Bicetre
country: France
city: Lyon
country: France
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Bremen
country: Germany
city: Muenster
country: Germany
city: Munchen
country: Germany
city: Firenze
country: Italy
city: Milano
country: Italy
city: Madrid
country: Spain
city: Valencia
country: Spain
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Italy, decresg@wyeth.com
name: Trail Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Spain, MedInfoNord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For UK, ukmedinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Belgium, trials-BEL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Germany, MedInfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References: