The Von Willebrand Disease (VWD) International Prophylaxis Study (VIP)
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Purpose
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 | Intervention |
|---|---|
|
Von Willebrand Disease |
Drug: VWF/FVIII products (see below) |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 13 |
| Study Start Date: | June 2007 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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. |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 | |
| Sweden | |
| 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 |
More Information
No publications provided
| Responsible Party: | Sharyne M. Donfield, Ph.D., Senior Research Scientist, Skane University Hospital |
| ClinicalTrials.gov Identifier: | NCT00557908 History of Changes |
| Other Study ID Numbers: | VWD PN |
| Study First Received: | November 13, 2007 |
| Last Updated: | February 26, 2013 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by Skane University Hospital:
|
Von Willebrand Disease VWD prophylaxis |
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 |
ClinicalTrials.gov processed this record on June 13, 2013