Conditions: Von Willebrand Disease
Allocation: NON_RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 49
Healthy volunteers: no

Brief summary:
The purpose of this Phase 3 study is to assess the pharmacokinetics of rVWF:rFVIII and rVWF, and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding events in subjects with severe hereditary von Willebrand disease (VWD).

Detailed description:

Arms:
arm 1: PK assessment (80 IU/kg rVWF) + 12-month treatment period arm 2: Two single-blinded PK assessments (50 IU/kg rVWF + rFVIII/placebo) + 12-month treatment period arm 3: PK assessment (50 IU/kg rVWF) only, no treatment of bleeding episodes arm 4: Treatment of bleeding episodes for a total of 12 months

Interventions: intervention 1: Recombinant von Willebrand factor (rVWF) intervention 2: Placebo intervention 3: Recombinant factor VIIII (rFVIII)
Intervention descriptions: intervention 1: Intravenous administration intervention 2: Syringe supplied with physiologic saline solution for infusion intervention 3: Intravenous administration

Protocol document: