EUCTR2004-000930-35-BE进行中（未招募）不适用
An open-label extension study to Study 100185 to evaluate long-term saftey, efficacy and optimal dosing frequency of 750mg intravenous mepolizumab in subjects with hypereosinophilic syndrome.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects who have participated in Study MHE100185
- •A female subject is eligible to enter the study if she is:
- •Not pregnant or nursing
- •Of non-childbearing potential (i.e., women who had a hysterectomy, are post-menopausal which is defined as 1 year without menses, have both ovaries surgically removed, or have current documented tubal ligation); or
- •Of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate.
- •These women must have a negative serum pregnancy test at the Screening Visit, and agree to one of the following:
- •- Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of investigational product until 3 months after the last dose of investigational product;
- •- Consistent and correct use of one of the following acceptable methods of birth control for one month prior to the start of the investigation product and three months after the last dose:
- •? Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subjects;
- •? Implants of levonorgestrel;
- •? Injectable progestogen;
- •? Any intrauterine device (IUD) with a documented failure rate of less than 1% per year;
- •? Oral contraceptives (either combined or progestogen only)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who have developed life-threatening or other serious illness or clinical manifestation deemed inappropriate for inclusion in the study per the principal investigator
- •Has any of the following abnormal laboratory values at the Week 36/EW Visit of Study MHE100185:
- •Serum creatinine > 3 times institutional upper limit normal (ULN)
- •AST or ALT > 5 times institutional ULN
- •Platelet count < 50, 000 per µL.
- •Has developed abnormal cardiac functions, as the following, within the past 3 months:
- •Left ventricular ejection fraction (LVEF) < 20%
- •NYHA class IIIb or IV.
- •Angina or acute myocardial infarction.
- •Has developed allergic reaction to Study MHE100185 investigational product.
- •Use of an investigational product as concurrent medication.
- •Does not complete Week36/EW Visit assessments requitred in Study MHE100185.
- •Has completed or been terminated from Study MHE100185 for more than 1 month.
- •Recent history or suspicion of current drug abuse or alcohol abuse within the last 6 months.
- •Positive pregnancy test at the Week36/EW Visit of Study MHE100185.
研究者
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