跳至主要内容
临床试验/NCT00294541
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

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

发起方
Icagen
申办方类型
Industry

研究点 (62)

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