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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00524342 |
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Date of registration:
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31/08/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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IL-11 in Women With Von Willebrand Disease and Refractory Menorrhagia
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Scientific title:
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Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Women With Type 1 Von Willebrand Disease and Refractory Menorrhagia |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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7 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00524342 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Margaret V. Ragni, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pittsburgh Medical Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Von Willebrand Disease
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Intervention(s)
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Drug: Oprelvekin, Interleukin 11, IL-11
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Primary Outcome(s)
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>50% Reduction in PBAC (Pictorial Blood Assessment Chart) at 6 Months
[Time Frame: 6 months]
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Secondary Outcome(s)
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No. of Subjects With Detectable VWF mRNA (Von Willebrand Factor Messenger RNA).
[Time Frame: The time frame is up to 7 months per subject.]
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No. of Subjects With IL-11 Associated Adverse Events.
[Time Frame: The time frame is up to 7 months per subject.]
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Secondary ID(s)
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PRO07040157
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Wyeth 102344
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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