Conditions: Hemophilia A
Keywords: Hemophilia A Factor VIII inhibitors vWF/FVIII rFVIII
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 303
Healthy volunteers: no

Brief summary:
The primary objective of the study is to assess the immunogenicity of VWF/FVIII and of rFVIII concentrates by determining the frequency of inhibitor development in previously untreated patients (PUPs) or minimally blood component-treated (MBCTPs) in the first 50 EDs or in the first 3 years from enrollment, whichever occurs first.

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Detailed description:
Patients meeting the enrollment criteria will be consecutively enrolled at each participating centre, randomized to be treated exclusively with a single FVIII product either plasma-derived or recombinant, and followed up until inhibitor development or until 50 exposure days (EDs) or 3 years from enrolment have elapsed, whichever comes first. Study products, belonging to the class of rFVIII concentrates and to the class of plasma-derived VWF/FVIII concentrates, will be provided for free to the patients for all the duration of the study

Arms:
arm 1: Plasma-derived vWF/FVIII arm 2: Recombinant FVIII

Interventions: intervention 1: PLASMA DERIVED Factor VIII intervention 2: Recombinant FVIII
Intervention descriptions: intervention 1: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding intervention 2: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding

Protocol document: