IL-11 in Adults With Von Willebrand Disease Undergoing Surgery
| Status: | Terminated |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | February 2008 |
| End Date: | June 2012 |
Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease Undergoing Surgery
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.
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.
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.
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.
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
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