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临床试验/NCT02720536
NCT02720536已完成3 期

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

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2016年8月16日最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Deferasirox

Experimental

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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