An observational study in Von Willebrand Disease, sponsored by Skane University Hospital. Completed at 3 sites in 2 countries. Per ClinicalTrials.gov, last updated 2017-10-06.
Sponsored by Skane University Hospital · Observational
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).
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.
63 studies on the registry are indexed under Von Willebrand Diseases; 4 are open to participants now.
This study's enrollment of 105 is close to the median of 102 across 31 observational studies indexed under Von Willebrand Diseases.
Browse Von Willebrand Diseases studies →Skane University Hospital is the lead sponsor of 71 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Type 2: eligible for participation if
Type 3: eligible for participation if
Bleeding Indication Criteria:
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
von Willebrand Disease associated bleeding frequency
Time frame: 1 year
Optimal treatment regimens for joint bleeding, GI bleeding, epistaxis, and menorrhagia
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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