SEVERE TYPE A HAEMOPHILIA MedDRA version: 9.1 Level: LLT Classification code 10010432 Term: Congenital deficiency of other clotting factors
Conditions
Interventions
Trade Name: FANHDI 250UI*1F 250UI+F 10ML
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Coagulation factor VIII
Concentration unit: IU/kg international unit(s)/
Sponsors
FONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMI
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: a. severe hemophilia A (FVIII 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
Exclusion criteria: see inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study is aimed to evaluate whether FVIII/vWF concentrates successfully induce immune tolerance in patients who have already experienced and failed immune tolerance induction with VWF-free FVIII concentrates.;Secondary Objective: I.Maintenance of immune tolerance II.Time to achieve success III.Safety - compliance to treatment IV.Cost of care;Primary end point(s): The study is aimed to evaluate whether FVIII/vWF concentrates successfully induce immune tolerance in patients who have already experienced and failed immune tolerance induction with VWF-free FVIII concentrates. | — |
Countries
Italy, Spain
Outcome results
None listed