IL-11 in Adults With Von Willebrand Disease Undergoing Surgery
NCT00524225
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | IL-11 in Adults With Von Willebrand Disease Undergoing Surgery | |||
| Official Title ICMJE | Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease Undergoing Surgery | |||
| Brief Summary | The purpose of this study is to determine the efficacy and safety of rhIL-11 when given subcutaneously in adults with type 1 von Willebrand disease undergoing elective surgery or major dental procedure. Efficacy will be measured by estimated blood loss, and frequency and severity of bleeding and transfusion requirement during and after surgery. Safety will be measured by the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema. | |||
| Detailed Description | This study is a prospective, single-center Phase II trial of Neumega (rhIL-11) in adults with type 1 VWD undergoing elective surgery or major dental procedure. It is anticipated that 10 subjects who meet eligibility criteria will enroll and complete the study. The specific objectives are to determine the efficacy and safety or rhIL-11 during and after elective surgery, and to determine the mechanism of the hemostatic response of rhIL-11. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
| Condition ICMJE | Von Willebrand Disease | |||
| Intervention ICMJE | Drug: Neumega (Oprelvekin, Interleukin 11, IL-11)
25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure | |||
| Study Arms ICMJE | Experimental: Neumega (Interleukin 11, IL-11)
Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively Intervention: Drug: Neumega (Oprelvekin, Interleukin 11, IL-11) | |||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Actual Enrollment ICMJE | 3 | |||
| Original Estimated Enrollment ICMJE | 10 | |||
| Actual Study Completion Date ICMJE | June 2012 | |||
| Actual Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00524225 | |||
| Other Study ID Numbers ICMJE | PRO07030210 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Margaret Ragni, University of Pittsburgh | |||
| Study Sponsor ICMJE | Margaret Ragni | |||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | University of Pittsburgh | |||
| Verification Date | June 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||