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Study Evaluating Inhibitor Specificity in Hemophilia A

Primary Purpose

Hemophilia A

Status

Withdrawn

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

single blood draw

About this trial

This is an interventional diagnostic trial for Hemophilia A

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Description of the patterns of antibodies and associated epitopes in a subset of

previously treated patients with hemophilia A.

Secondary Outcome Measures

Full Information

NCT ID

NCT00151385

First Posted

September 6, 2005

Last Updated

June 26, 2012

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00151385

Brief Title

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

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Withdrawn

Study Start Date

November 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemophilia A

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

single blood draw

Primary Outcome Measure Information:

Title

Description of the patterns of antibodies and associated epitopes in a subset of

Title

previously treated patients with hemophilia A.

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: