NCT00266565已完成1 期
A Phase I/II Study of the Effect of Intravenous Anti-IL-5 (Mepolizumab) SB 240563 on the Outcome and Management of Hypereosinophilic Syndromes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To assess the toxicity of anti-IL-5 in patients with hypereosinophilia
研究概览
简要总结
Toxicity of anti-IL-5
详细描述
The purpose of the study is to assess the toxicity of anti-IL-5, and to see whether it lowers peripheral blood eosinophils and/or tissue and whether it has a steroid and/or interferon sparing effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adequate renal, cardiac, and hepatic function
- •Not pregnant or breastfeeding
- •A diagnosis of hypereosinophilic syndrome such as:
- •Idiopathic hypereosinophilic syndrome;
- •Eosinophilia myalgia syndrome;
- •Eosinophilic gastroenteritis;
- •Churg-Strauss syndrome;
- •Eosinophilic cellulitis;
- •Benign hypereosinophilia; or
- •Eosinophilic esophagitis.
- •Maintained on, or in need of, the following: glucocorticoids, interferon, methotrexate, hydroxyurea, cytoxan, 6-mercaptopurine, or vincristine
- •Blood eosinophil counts greater than 750 cells/mcl
排除标准
- •Creatinine > 3 X upper limit for age
- •AST > 5 X upper limit for age
- •Platelet count < 50,000/mm3
- •Cardiac function:
- •NYHA class IIIb or IV (patients with shortness of breath or fatigue with mild exertion or at rest);
- •Patients with symptomatic supraventricular or ventricular arrythmias requiring treatment;
- •Patients requiring IV heart failure medications;
- •Angina or acute myocardial infarction
- •History of renal, hepatic, endocrine, oncologic, cardiovascular disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the patient or impact on the validity of the study results
- •History of allergic or adverse response to previous antibody type therapy
- •History of allergic or adverse response to anti-IL-5 therapy
- •Evidence of, or history of, a parasitic infection (within past 1 year)
- •Participation in a previous clinical trial involving an investigational agent within 30 days prior to study initiation
- •Receipt of anti-IL-5 therapy in the past
- •Blood donation of 450 ml (1 pint) or more within 30 days prior to study initiation
- •Abnormal or unusual diet or substantial changes in eating habits within 30 days prior to, or during, the study.
- •Patients who do not have eosinophil levels > 750 cells/mcl after the run-in period. Patients who have only eosinophilic infiltration of tissue are eligible if they do not develop an eosinophil level > 750 cells/mcl, assuming that they meet all other eligibility requirements.
- •Positive serum pregnancy test
- •Breastfeeding
- •Unable to use effective birth control methods for duration of study
- •Unable or unwilling to give voluntary informed consent/assent
研究组 & 干预措施
Anti-IL5 (Mepolizumab)
Experimental
The purpose of the study is to assess the toxicity of anti-IL-5 (Mepolizumab), and to see whether it lowers eosinophils in peripheral blood and/or tissue and whether it has a steroid and/or interferon sparing effect.
干预措施: Mepolizumab (Drug)
结局指标
主要结局
To assess the toxicity of anti-IL-5 in patients with hypereosinophilia
时间窗: 28 weeks
次要结局
- To assess whether anti-IL-5 lowers peripheral blood eosinophils and/or tissue in patients with hypereosinophilia(28 weeks)
- To assess whether anti-IL-5 has a steroid and/or interferon sparing effect(28 weeks)
研究者
研究点 (1)
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