Phase II Study of IL-11 (Neumega) in Von Willebrand Disease

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is testing the use of rhIL-11 (recombinant interleukin 11, Neumega) in individuals with Von Willebrand disease. The purpose is to evaluate:

1. if rhIL-11 corrects VWF (Von Willebrand Factor) levels to normal

2. if rhIL-11 and DDAVP together will boost VWF levels even higher

3. the onset, peak, and duration of rhIL-11 effect

4. if rhIL-11 is safe in individuals with Von Willebrand Disease

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborators: University of North Carolina; Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Hemostatics; Oprelvekin

Criteria

Inclusion Criteria:

• Males and females 18 years of age or older

• Confirmed VWD by 2 of 4 VWD coagulation tests abnormal

• A past bleeding history

• No hormone, oral contraceptive, estrogen use in past 8 weeks

• Willingness to have blood drawn

• Willingness to sign informed consent

Exclusion Criteria:

• Presence of other bleeding disorder, e.g. acquired VWD, thrombocytopenia

• Use of estrogens, hormones, oral contraceptives in past 8 weeks

• Use of immunomodulatory or experimental drugs or diuretics

• Pregnant or lactating women

• Past 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 FVIII, VWF within 5 days of study