EUCTR2016-004322-42-Outside-EU/EEA进行中（未招募）1 期
Efficacy and safety of long-term treatment with ICL670 in beta-thalassemia patients with transfusional hemosiderosis
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
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
- •Patients completing the planned 12-month core study (NCT00171171)
- •Female patients who have reached menarche and who are sexually active must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation
- •Written informed consent obtained from the patient and/or legal guardian on the patient's behalf in accordance with the national legislation
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 162
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 69
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant or breast feeding patients.
- •Patients being considered by the investigator potentially unreliable and/or not cooperative with regard to the core study protocol, or the planned extension protocol
研究者
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