Study Evaluating Inhibitor Specificity in Hemophilia A

Wyeth

Status and phase: Withdrawn; Phase 4

Conditions: Hemophilia A

Treatments: Procedure: single blood draw

Study type: Interventional

Funder types: Industry

Identifiers

NCT00151385

3082A-101342

Details and patient eligibility

About

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.

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)