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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: |
NCT00524225 |
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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 Adults With Von Willebrand Disease Undergoing Surgery
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Scientific title:
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Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease Undergoing Surgery |
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Date of first enrolment:
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February 2008 |
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Target sample size:
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3 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00524225 |
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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:
- Males and females 18 years of age and older
- Confirmed type 1 VWD, as defined by low VWF:RCoF or low VWF:Ag and qualitatively
normal VWF multimers
- A past bleeding history
- Responsive to DDAVP
- Scheduled elective major surgery or major dental surgery at MUH or PUH
- Willingness to have blood drawn
Exclusion Criteria:
- Presence of other bleeding disorders, acquired Von Willebrand disease, primary
thrombocytopenia
- 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
- 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:
N/A
Gender:
All
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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: Neumega (Oprelvekin, Interleukin 11, IL-11)
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Primary Outcome(s)
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Volume of Blood Transfusion
[Time Frame: 4 weeks]
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Volume of Surgical Blood Loss
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Number of Subjects Who Experienced Adverse Events
[Time Frame: The time frame is within 4 weeks of surgery.]
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No. of Subjects With Detectable VWFmRNA (Von Willebrand Factor Messenger RNA).
[Time Frame: 4 weeks per subject]
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Secondary ID(s)
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PRO07030210
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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