Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease Undergoing Surgery
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Volume of Surgical Blood Loss
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Neumega (Oprelvekin, Interleukin 11, IL-11) (Drug)
结局指标
主要结局
Volume of Surgical Blood Loss
时间窗: 4 weeks
Hemostatic efficacy was measured by estimated blood loss (cc) during the surgical procedure.
Volume of Blood Transfusion
时间窗: 4 weeks
The volume of blood transfusion required (units of blood) after the surgical procedure.
次要结局
- No. of Subjects With Detectable VWFmRNA (Von Willebrand Factor Messenger RNA).(4 weeks per subject)
- Number of Subjects Who Experienced Adverse Events(The time frame is within 4 weeks of surgery.)
研究者
Margaret Ragni
Professor
University of Pittsburgh