The Von Willebrand Disease (VWD) International Prophylaxis Study (VIP)
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).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||The VWD International Prophylaxis (VIP) Study|
- von Willebrand Disease associated bleeding frequency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Optimal treatment regimens for joint bleeding, GI bleeding, epistaxis, and menorrhagia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
|Infusions per week/menstrual cycle||
Drug: VWF/FVIII products (see below)
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
VWF/FVIII products labeled for use in the treatment of VWD will be chosen for use at the discretion of the treating physician. Examples of such products include, but are not limited to, Humate P/Haemate P, Alphanate, Wilate, and Fanhdi.
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.
|United States, North Carolina|
|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|
|Principal Investigator:||Erik Berntorp, MD, PhD||Skåne University Hospital, Malmö, Sweden|
|Principal Investigator:||Thomas Abshire, MD||Blood Center of Wisconsin|