Open-label, Multicenter, Single Arm, Phase III Study to Collect Additional Safety and Efficacy Data With Deferasirox Film-coated Tablets in Patients Completing Study CICL670F2201
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change From Baseline Creatinine Clearance (mL/Min) at Month 6 and Month 12
研究概览
简要总结
Extend evaluation of deferasirox film-coated tablet (FCT) formulation
详细描述
Collection of additional safety and efficacy data with deferasirox film-coated tablet (FCT) in patients who had completed study CICL670F2201
- Provide patients who completed 24 weeks of treatment in the core study, CICL670F2201, the possibility to have additional treatment with the deferasirox FCT.
- Collect additional longer term data on the safety and the tolerability of the deferasirox FCT.
- Collect efficacy data on the deferasirox FCT in reduction or maintenance of iron burden as measured by serum ferritin level.
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
- 10 Years 至 —(Child, 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
Deferasirox
Treatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight.
干预措施: Deferasirox (Drug)
结局指标
主要结局
Change From Baseline Creatinine Clearance (mL/Min) at Month 6 and Month 12
时间窗: Baseline, 6 and 12 months
The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Change From Baseline Alanine Aminotransferase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) (U/L) at Month 6 and Month 12
时间窗: Baseline, 6 and 12 months
The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Change From Baseline Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) (U/L) at Month 6 and Month 12
时间窗: Baseline, 6 and 12 months
The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Change From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12
时间窗: Baseline, 6 and 12 months
The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Change From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12
时间窗: Baseline, 6 and 12 months
The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Change From Baseline Serum Creatinine (Umol/L) at Month 6 and Month 12
时间窗: Baseline, 6 and 12 months
The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Overview of Number of Participants With Adverse Events
时间窗: Baseline up to approximately 25 months
Numbers represent counts of participants within the categories. An adverse event (AE) was defined as treatment emergent if its onset date is on or after (≥) the first administration of study treatment within this study or events present prior to start of study treatment but increased in severity on or after (≥) the first administration of study treatment within this study but not later than 30 days after the last study treatment in this study
Change From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12
时间窗: Baseline, 6 and 12 months
The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
次要结局
- Change From Baseline of Serum Ferritin Level (ug/L) at Month 6 and 12(Baseline, 6 and 12 months)
- Percentage Relative Change From Baseline of Serum Ferritin (%) at Month 6 and 12(Baseline, 6 and 12 months)
