Phase II Study of IL-11 (Neumega) in Von Willebrand Disease
Von Willebrand Disease
About this trial
This is an interventional treatment trial for Von Willebrand Disease focused on measuring Von Willebrand Disease, Bleeding, Coagulation, Hemostatic agent
Eligibility 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
Sites / Locations
- Hemophilia Center of Western Pennsylvania and General Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
A
B
C
rhIL-11 (Interleukin-11, Neumega) 25 mcg/kg subcutaneously daily for 7 days
rhIL-11 (interleukin-11, Neumega) 50 mcg/kg subcutaneously daily for 7 days
rhIL-11 (Interleukin-11, Neumega) 10 mg/kg subcutaneously daily for 7 days