EUCTR2006-001652-12-FR进行中（未招募）1 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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Icagen Inc.
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject has successfully completed Study 10;
- •2. Male, or female not capable of becoming pregnant or using appropriate birth control method. Acceptable methods - Postmenopausal as defined by absent menses for more than or equal to 12 months; Hysterectomy; Bilateral ovariectomy; Bilateral tubal ligation (if surgery more than or equal to 12 months previous); Hormonal contraception with 1 barrier method*; Double barrier method*; Abstinence;
- •*Barrier methods include use of a diaphragm or sponge with
- •spermicidal cream or jelly, and/or condom use by sexual partner
- •3. Has willingly given written informed consent to participate in this investigation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. The subject, if female, has a positive urine pregnancy test (dipstick) on Day 1;
- •2. The subject is presently unsuitable for participation in this long-term study (e.g., safety considerations, planning surgery).
研究者
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