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The Von Willebrand Disease (VWD) International Prophylaxis Study

NCT00557908 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2017-10-06

No results posted yet for this study

Summary

The von Willebrand Disease Prophylaxis Network (VWD PN) is an international study group formed with the goal of investigating the role of prophylaxis in clinically severe VWD that is non-responsive to other treatment(s).

Conditions

  • Von Willebrand Disease

Interventions

DRUG

VWF/FVIII products

Participants in the prospective phase of the study undergo an escalation of treatment from receipt of one to three levels of VWD product. All subjects enrolled will begin treatment on the level one and remain on this regimen for the duration of follow-up, or until they meet the criteria for escalation to level two or three (if indeed they do meet the criteria.) Dosing for joint bleeding, epistaxis, and GI bleeding indications: 50 U RCo/kg once per week, 50 U RCo/kg twice per week, or 50 U RCo/kg three times per week. Dosing for menorrhagia: 50 U RCo/kg on day 1 of menses for 2 cycles, 50 U RCo/kg on days 1 and 2 of menses for 2 cycles, or 50 U RCo/kg on days 1, 2, and 3 of menses

Sponsors & Collaborators

  • Versiti

    collaborator OTHER

  • CSL Behring

    collaborator INDUSTRY

  • Skane University Hospital

    lead OTHER

Principal Investigators

  • Erik Berntorp, MD, PhD · Skåne University Hospital, Malmö, Sweden

  • Thomas Abshire, MD · Versiti

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00557908 on ClinicalTrials.gov