Overview

IL-11 in Adults With Von Willebrand Disease Undergoing Surgery

Status:
Terminated
Trial end date:
2012-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the efficacy and safety of rhIL-11 when given subcutaneously in adults with type 1 von Willebrand disease undergoing elective surgery or major dental procedure. Efficacy will be measured by estimated blood loss, and frequency and severity of bleeding and transfusion requirement during and after surgery. Safety will be measured by the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Margaret Ragni
University of Pittsburgh
Collaborators:
University of North Carolina
Wyeth is now a wholly owned subsidiary of Pfizer
Treatments:
Oprelvekin
Criteria
Inclusion Criteria:

- Males and females 18 years of age and older

- Confirmed type 1 VWD, as defined by low VWF:RCoF or low VWF:Ag and qualitatively
normal VWF multimers

- A past bleeding history

- Responsive to DDAVP

- Scheduled elective major surgery or major dental surgery at MUH or PUH

- Willingness to have blood drawn

Exclusion Criteria:

- Presence of other bleeding disorders, acquired Von Willebrand disease, primary
thrombocytopenia

- Use of immunomodulatory or experimental drugs, or diuretics

- Pregnant or lactating women or those unwilling to use contraception during study

- Previous cardiac disease, congestive failure, arrhythmia (e.g. atrial fibrillation,
atrial flutter), hypertension, MI, stroke, or thrombosis

- Past allergic reaction to Neumega or DDAVP

- Surgery within the past 8 weeks

- Inability to comply with study protocol requirements

- Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs

- Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives
containing substantial quantities of FVIII and/or VWF within five days of study

- Past allergic reaction to Neumega or DDAVP

- Surgery within the past 8 weeks

- Inability to comply with study protocol requirements

- Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs

- Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives
containing substantial quantities of FVIII and/or VWF within five days of study