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Pittsburgh, Pennsylvania 15213

  • Von Willebrand Disease

Purpose:

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


Study summary:

This is a prospective, single center, open-label, escalating dose Phase II comparison study of interleukin-11 (rhIL-11, Neumega) in subjects with type 1 Von Willebrand Disease (VWD). The purpose is to establish the clinical safety and hemostatic efficacy of rhIL-11 in individuals with type 1 Von Willebrand disease. Study subjects will include the following subjects: 1. age >= 18 years of age 2. diagnosis of VWD confirmed by: 2a) at least 2 of 4 abnormal vWD-related coagulation tests; 2b) a past bleeding history A total of 10-16 subjects are anticipated to be enrolled and complete the study. The specific aims of the study are: 1. to compare the hemostatic efficacy of three escalating doses of rhIL-11 2. to determine the biologic effects of rhIL-11 3. to determine whether DDAVP, when given after the seventh daily dose of rhIL-11, enhances hemostatic efficacy or rhIL-11 4. to compare the safety of three escalating doses of rhIL-11 Efficacy will be based on the number and percent increase of VWD-related coagulation tests into the normal range, or at least to 2-3 times baseline. Safety will be based on the number and frequency of adverse reactions, including fever, headache, fatigue, arthralgias, myalgias, fluid retention, and edema. The study will last up to 4 weeks per subject, and for 24 months for the entire study.


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


NCT ID:

NCT00151125


Primary Contact:

Principal Investigator
Margaret V. Ragni, MD, MPH
University of Pittsburgh


Backup Contact:

N/A


Location Contact:

Pittsburgh, Pennsylvania 15213
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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