Study Evaluating Inhibitor Specificity in Hemophilia A

June 26, 2012 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Michigan
      • Detroit, Michigan, United States, 48201
    • New York
      • New Hyde Park, New York, United States, 11040
      • New York, New York, United States, 10021
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19134
    • Texas
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Description of the patterns of antibodies and associated epitopes in a subset of
previously treated patients with hemophilia A.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Trail Manager, For Italy, decresg@wyeth.com
  • Principal Investigator: Trial Manager, For Spain, MedInfoNord@wyeth.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

June 28, 2012

Last Update Submitted That Met QC Criteria

June 26, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3082A-101342

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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