RANDOMISED STUDY OF FIRST CHOICE IMMUNOTOLERANCE INDUCTION IN PATIENTS WITH SEVERE TYPE A HAEMOPHILIA WITH INHIBITOR AT HIGH RISK OF FAILURE: COMPARISON OF INDUCTION OF IMMUNE TOLERANCE WITH FVIII CONCENTRATES WITH OR WITHOUT VON WILLEBRAND FACTOR?Estudio randomizado que consiste en administrar por primera vez un tratamiento de inducción de inmunotolerancia en pacientes con hemofilia a grave con inhibidor y alto riesgo de fracaso: comparación de inducción de inmunotolerancia con concentrados de FVIII con o sin factor Von Willebrand?

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

• Registration Number: EUCTR2008-007016-15-ES
• Lead Sponsor: FONDAZIONE CHARTA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 148

Inclusion Criteria

a. severe hemophilia A (FVIII<1%) b. male patients, any age; c. high responders (peak inhibitor levels > 5 BU); d. any inhibitor level at study enrolment; e. ability and willingness to participate in to the study; f. 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. no concomitant experimental treatment; h. at least one of the following risk factors for ITI failure: i. peak inhibitor titer > 200 BU ii. titer at ITI start > 10 BU iii. age > 7 years iv. time between inhibitor occurrence and ITI > 2 years i. no previous ITI attempt.
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