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Clinical trial

Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD)

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Last updated:1st Sep 2011

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).

 

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3 Clinical Study to Determine the Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor : Recombinant Factor VIII (rVWF:rFVIII) and rVWF in the Treatment of Bleeding Episodes in Subjects Diagnosed With Von Willebrand Disease
Enrollment: 49
Study Start Date: September 2011
Study Completion Date: February 2014
Primary Completion Date:  February 2014 (Final data collection date for primary outcome measure)

Arms:
- Experimental: PK 80 Arm (minimum of 22 subjects with severe VWD)
- Experimental: PK 50 Arm (14 subjects with type 3 VWD)
- Experimental: PK 50 Only Arm (minimum of 7 subjects with type 3 VWD)
- Experimental: Treatment Only (up to 7 subjects independent of VWD subtype)

Category Value
Study start date 2011-09-01

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