CompletedPhase 3

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

United States49 participantsStarted 2011-11-01

Plain-language 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).

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Type 1 (Von Willebrand factor: Ristocetin cofactor activity (VWF:RCo) \< 20 IU/dL) or,
✓. Type 2A (VWF:RCo \< 20 IU/dL), Type 2B (as diagnosed by genotype), Type 2N (Factor VIII activity (FVIII:C) \<10% and historically documented genetics), Type 2M or,
✓. Type 3 ( Von Willebrand factor antigen (VWF:Ag) ≤ 3 IU/dL) or,
✓. Severe Von Willebrand disease (VWD) with a history of requiring substitution therapy with von Willebrand factor concentrate to control bleeding

What they're measuring

Percentage of Participants With Treatment Success for Treated Bleeding Episodes

Timeframe: For 12 months after first infusion of rVWF:rFVIII or rVWF

Trial details

NCT IDNCT01410227

SponsorBaxalta now part of Shire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-02-01

Results submitted2016-03-21

View on ClinicalTrials.gov More Von Willebrand Disease trials