The Von Willebrand Disease (VWD) International Prophylaxis Study

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00557908
• Date of registration: 13/11/2007
• Prospective Registration: No
• Primary sponsor: Skane University Hospital
• Public title: The Von Willebrand Disease (VWD) International Prophylaxis Study VIP
• Scientific title: The VWD International Prophylaxis (VIP) Study
• Date of first enrolment: June 2007
• Target sample size: 105
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00557908
• Study type: Observational
• Phase: N/A

Countries of recruitment

Sweden, United States

Contacts

• Name: Erik Berntorp, MD, PhD
• Affiliation: Skåne University Hospital, Malmö, Sweden

• Name: Thomas Abshire, MD
• Affiliation: Blood Center of Wisconsin

Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Von Willebrand Disease

Intervention(s)

Drug: VWF/FVIII products

Primary Outcome(s)

von Willebrand Disease associated bleeding frequency [Time Frame: 1 year]

Secondary Outcome(s)

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

Secondary ID(s)

VWD PN

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Blood Center of Wisconsin

CSL Behring