NCT00294541终止3 期
An Open-Label Extension Study Evaluating the Long-Term Safety of ICA-17043 With or Without Hydroxyurea Therapy in Subjects With Sickle Cell Disease
Icagen62 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2006年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 51
- 试验地点
- 62
- 主要终点
- Safety measures only
研究概览
简要总结
This trial is a follow-up companion study to Protocol ICA-17043-10, a Phase III, multi-center, efficacy and safety study of ICA-17043. This is an open-label extension study collecting safety data on the use of ICA-17043 in subjects with sickle cell disease (SCD) (e.g., HbSS, HbSC, HbSb0-thalassemia, HbSb+-thalassemia subjects). All subjects who have successfully completed ICA-17043-10 will, if deemed appropriate by their study Investigator and appropriate consent by subject is given, enroll in the ICA-17043-12 study (Study 12). Only patients who participated in ICA-17043-10 are eligible for this open label study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 66 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Successfully completed Study ICA-17043-10
- •Discontinued Study 10 or 12 following the DMC recommendations because he/she was not on HU, and has since been on a stable dose of HU for at least 3 months prior to Day 1
- •Male, or female not capable of becoming pregnant or using appropriate birth control
- •Has willingly given written informed consent to participate in this study
排除标准
- •The subject, if female, has a positive urine pregnancy test on Day 1 (before entering study)
- •The subject is presently unsuitable for participation in this long-term study
结局指标
主要结局
Safety measures only
时间窗: at least 60 weeks
No efficacy outcome measures
次要结局
未报告次要终点
研究者
研究点 (62)
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