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