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

Completed · Phase 2

Conditions studied: Von Willebrand Disease

In brief

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

Key facts

Study ID

NCT00151125

Run by

University of Pittsburgh

People needed

12

Starts

2004-07-01

Expected to finish

2007-12-01

Last updated by the study team

2016-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hemophilia Center of Western Pennsylvania and General Clinical Research Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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