IL-11 in Women With Von Willebrand Disease and Refractory Menorrhagia

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine the efficacy and safety of rhIL-11, when given subcutaneously for six consecutive months, in reducing menstrual blood loss in women with type 1 von Willebrand disease and refractory menorrhagia. Efficacy will be measured by subjective bleeding severity scale and pictorial bleeding chart. 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:

• Females 18-45 years of age

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

• Menorrhagia refractory to estrogens, hormones, hemostatic agents

• Willingness to have blood drawn

Exclusion Criteria:

• 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