IMMUNE TOLERANCE INDUCTION STUDY IN PATIENTS WITH SEVERE TYPE A HAEMOPHILIA WITH INHIBITOR AFTER FAILURE OF A PREVIOUS INDUCTION OF IMMUNE TOLERANCE WITH FVIII CONCENTRATES WITHOUT VON WILLEBRAND FACTOREstudio de Inducción de Inmunotolerancia en pacientes con hemofilia A grave con inhibidor tras fracaso previo en Inducción de Inmunotolerancia utilizando concentrados de FVIII sin factor Von Willebrand

• Conditions: SEVERE TYPE A HAEMOPHILIA; MedDRA version: 9.1Level: LLTClassification code 10010432Term: Congenital deficiency of other clotting factors

• Registration Number: EUCTR2008-007019-33-ES
• Lead Sponsor: FONDAZIONE CHARTA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-29
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

a. severe hemophilia A (FVIII<1%) b. male patients, any age; c. high responders (peak inhibitor levels > 5 BU); d. with any inhibitor level at study enrolment; e. with ability and willingness to participate to the study; f. with no concomitant systemic treatment with drugs with immunosuppressive side effects (eg. Corticosteroids, if used more than 5 days every iii months and/or at a dose of > 2mg/kg or 60 mg/day, azathioprine, cyclophosphamide, high?dose immunoglobulin as well as the use of a protein A column or plasmapheresis, interferons);g. with no concomitant experimental treatment. h. previous ITI course of at least 9 monthswith a VWF-free FVIII concentrate at any dosage, such as recombinant FVIII and/or monoclonally purified FVIII. i. patients who initially succeeded to clear the inhibitor and then relapsed can be included
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

see inclusion criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified