IL-11 in Adults With Von Willebrand Disease Undergoing Surgery

Margaret Ragni

Status and phase: Terminated; Phase 2

Conditions: Von Willebrand Disease

Treatments: Drug: Neumega (Oprelvekin, Interleukin 11, IL-11)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00524225

PRO07030210

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Neumega (Interleukin 11, IL-11)

Experimental group

Description:

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

Treatment:

Drug: Neumega (Oprelvekin, Interleukin 11, IL-11)