We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

The Von Willebrand Disease (VWD) International Prophylaxis Study (VIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00557908
Recruitment Status : Completed
First Posted : November 14, 2007
Last Update Posted : October 6, 2017
Information provided by (Responsible Party):

Study Description
Brief 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).

Condition or disease Intervention/treatment
Von Willebrand Disease Drug: VWF/FVIII products

Detailed Description:
The most common indications for vWD prophylaxis included joint bleeding, epistaxis, gastrointestinal (GI) bleeding, and menorrhagia. Thus, an effort to establish optimal treatment regimens for these indications, through a period of prospective evaluation, is the primary focus of this research. Other goals include a retrospective study of the effect of prophylaxis on bleeding frequency, and a retrospective natural history study of GI bleeding in VWD.

Study Design

Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The VWD International Prophylaxis (VIP) Study
Study Start Date : June 2007
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
VWF/FVIII product infusions
One to three infusions of factor replacement as needed to control bleeding.
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

Outcome Measures

Primary Outcome Measures :
  1. von Willebrand Disease associated bleeding frequency [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Optimal treatment regimens for joint bleeding, GI bleeding, epistaxis, and menorrhagia [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The VWD population includes those with Type 1 if </=20% RCo and/or </=20% FVIII; and DDAVP non-responsive; Type 2 if DDAVP non-responsive, or Type 2B; and Type 3; who meet bleeding indication criteria having defined patterns of gastrointestinal bleeding, joint bleeding, epistaxis, or menorrhagia.

Individuals already on prophylaxis for VWD, for any indication, and individuals who were on a regimen of prophylaxis for at least six months that was discontinued because it was no longer required, or those with a history of GI bleeding due either to proven angiodysplasia or unexplained by other factors.


Inclusion Criteria:

Type 1: eligible for participation if

  • ≤20% RCo and/or ≤20% FVIII; and
  • DDAVP non-responsive, defined as occurrence of bleeding episodes not responding satisfactorily to desmopressin, or deemed non-responsive a priori by the investigator; and
  • Bleeding indication criteria are met

Type 2: eligible for participation if

  • DDAVP non-responsive, defined as occurrence of bleeding episodes not responding satisfactorily to desmopressin, or deemed non-responsive a priori by the investigator; or Type 2B;
  • Bleeding indication criteria are met

Type 3: eligible for participation if

  • Bleeding indication criteria are met

Bleeding Indication Criteria:

  • Joint Bleeding: documentation of at least two apparently spontaneous bleeding episodes in the same joint in the six months prior to enrollment; or three or more apparently spontaneous bleeding episodes in different joints in the six months prior to enrollment.
  • GI Bleeding: history of two or more severe GI bleeding episodes associated with either a drop in hemoglobin of ≥ 2 g/dl or requiring red blood cell transfusion or treatment with VWD concentrate.
  • Failure to identify other causes of bleeding.
  • Menorrhagia: a diagnosis of menorrhagia; prospectively completed Pictorial Blood Assessment Chart score >185 or required treatment with a VWD product for menstrual bleeding on one or more occasions in the year prior to enrollment.
  • Normal cervical cytology (PAP) within the six months prior to enrollment for females ≥ 18 years of age.
  • Epistaxis 1. Three or more bleeding episodes in a six-month period that required treatment with VWD concentrates or red cell transfusions.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00557908

United States, North Carolina
Rho, Inc.
Chapel Hill, North Carolina, United States, 27517
United States, Wisconsin
BloodCenter of Wisconsin
Milwaukee, Wisconsin, United States, 53201-2178
Skåne University Hospital
Malmö, Sweden, SE-20502
Sponsors and Collaborators
Skane University Hospital
Blood Center of Wisconsin
CSL Behring
Principal Investigator: Erik Berntorp, MD, PhD Skåne University Hospital, Malmö, Sweden
Principal Investigator: Thomas Abshire, MD Blood Center of Wisconsin
More Information

Responsible Party: Sharyne M. Donfield, Ph.D., Principal Research Scientist, Skane University Hospital
ClinicalTrials.gov Identifier: NCT00557908     History of Changes
Other Study ID Numbers: VWD PN
First Posted: November 14, 2007    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sharyne M. Donfield, Ph.D., Skane University Hospital:
Von Willebrand Disease

Additional relevant MeSH terms:
Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn