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Study Evaluating Inhibitor Specificity in Hemophilia A

NCT ID: NCT00151385

Last Updated: 2012-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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single blood draw

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trail Manager

Role: PRINCIPAL_INVESTIGATOR

For Italy, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Spain, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For UK, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Belgium, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Germany, [email protected]

Locations

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Atlanta, Georgia, United States

Site Status

Detroit, Michigan, United States

Site Status

New Hyde Park, New York, United States

Site Status

New York, New York, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Houston, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Brussels, , Belgium

Site Status

Leuven, , Belgium

Site Status

La Bouëxière, , France

Site Status

Le Kremlin-Bicêtre, , France

Site Status

Lyon, , France

Site Status

Berlin, , Germany

Site Status

Bonn, , Germany

Site Status

Bremen, , Germany

Site Status

München, , Germany

Site Status

Münster, , Germany

Site Status

Florence, , Italy

Site Status

Milan, , Italy

Site Status

Madrid, , Spain

Site Status

Valencia, , Spain

Site Status

London, , United Kingdom

Site Status

Manchester, , United Kingdom

Site Status

Countries

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United States Belgium France Germany Italy Spain United Kingdom

Other Identifiers

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3082A-101342

Identifier Type: -

Identifier Source: org_study_id

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