An Open Label Extension Study to Evaluate Safety and Efficacy of Mepolizumab in Patients With Hypereosinophilic Syndromes
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Number of Participants With Any Adverse Event (AE) During the Treatment Phase
研究概览
简要总结
This is an open label study of mepolizumab 750 mg intravenous in those subjects who participated in study 100185 to evaluate the long term safety and efficacy of mepolizumab in subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing frequency for clinical use, the effects on corticosteroid reduction, and decrease of signs and symptoms of Hypereosinophilic Syndrome.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
mepolizumab
750mg Intravenous, monthly and individual dosing schedule
干预措施: mepolizumab (Drug)
结局指标
主要结局
Number of Participants With Any Adverse Event (AE) During the Treatment Phase
时间窗: From the first dose of study medication up to 7 days after the last dose (up to approximately 6 years)
An AE is any untoward medical occurrence in clinical investigation participants temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs are summarized by Treatment phase. Safety and tolerability of the study drug was assessed by number of participants with any AE
Number of Participants With Any Adverse Event (AE) During the Follow-up Phase
时间窗: From end of Treatment Phase up to 97 days after the last dose date (up to approximately 6 years)
An AE is any untoward medical occurrence in clinical investigation participants temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs are summarized by Follow-up phase. Safety and tolerability of the study drug was assessed by number of participants with any AE
次要结局
- Number of Participants Achieving a Prednisone Level of =<10 mg (as Sole Background Therapy) at the End of Study(up to approximately 6 years)
- For Those Participants Who Completed 9 Months of Dosing in Study MHE100185 and Achieved a Prednisone Level <=10 mg: Number of Participants Achieving <= 10 mg Prednisone (as Sole Background Therapy) for >= 3months(up to approximately 6 years)
- Number of Participants Achieving an Eosinophil Level of < 600 Cell/Microliter (uL) (in Addition to the Lowest Background Therapy) at the End of Study(up to approximately 6 years)
- For Those Participants Who Completed 9 Months of Dosing in Study MHE100185 and Achieved a Prednisone Level >10 mg: Number of Participants Achieving <=10 mg Prednisone (as Sole Background Therapy) for >= 8 Weeks(up to approximately 6 years)
- For Those Participants Who Entered Stage 2 From Study MHE100185 With a Prednisone Level of <=10 mg Prednisone: Number of Participants Achieving a Prednisone Dose <=10 mg (as Sole Background Therapy) for >=3 Months;(up to approximately 6 years)
- For Those Participants Who Entered Stage 1 From Study MHE100185 With >10 mg Prednisone: Number of Participants Achieving a Prednisone Dose <=10 mg (as Sole Background Therapy) for>=3 Months(up to approximately 6 years)
- Blood Eosinophil Count (With Consideration of the HES Background Therapy) During Stages 1-3(up to approximately 6 years)
- Number of Participants by Dosing Frequency Groups (Defined as Two Week Dosing Ranges Greater Than a 4 Week Interval) at the End of Stage 2(up to approximately 6 years)
- Change From Baseline in the Pruritus Visual Analogue Scale (pVAS) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter(Baseline and up to approximately 6 years)
- Change From Baseline in Erythema/Edema Score 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter(Baseline and up to approximately 6 years)
- Change From Baseline in Quality of Life (QoL) and Current Health Status: Physical Summary Score of the Study Short Form Health Survey (SF-12) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter(Baseline and up to approximately 6 years)
- Change From Baseline in QoL and Current Health Status: Mental Summary Score of the SF12 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter(Baseline and up to approximately 6 years)