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.

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00151385

Enrollment

Registered

2005-09-08

Start date

2005-11-30

Completion date

2007-10-31

Last updated

2012-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

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.

Interventions

PROCEDUREsingle blood draw

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

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

Countries

Belgium, France, Germany, Italy, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026