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

Completed · Phase 2

Conditions studied: Von Willebrand Disease

In brief

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.

Key facts

Study ID

NCT00524342

Run by

Margaret Ragni

People needed

7

Starts

2008-01-01

Expected to finish

2010-12-01

Last updated by the study team

2018-01-31

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hemophilia Center of Western PA — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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