CompletedPhase 2

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

United States12 participantsStarted 2004-07

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The number and percent increase of VWD coagulation tests after seven daily doses of rhIL-11, boosted by DDAVP day 7.

Timeframe: The time frame is up to 14 days per subject.

Trial details

NCT IDNCT00151125

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-12

View on ClinicalTrials.gov More Von Willebrand Disease trials