NCT02274233终止1 期
Multicenter, Open-label, Dose-escalation Study of SP-420 in Subjects With Transfusion-dependent β-Thalassemia
Sideris Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
The purpose of this study is to assess safety and amount of the study drug in the blood after increasing doses of SP-420. The study will be conducted in patients with β-thalassemia.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has iron-overload secondary to β-thalassemia requiring chronic red blood cell transfusions and iron chelation therapy
- •Subject weighs ≥35 kg
- •Subject is willing to discontinue current iron chelation therapy at least 7 days prior to the first dose of SP-420 and for the duration of the study
- •Serum ferritin ≥700 ng/mL and iron saturation ≥70% within 3 weeks before Baseline (Day 1)
- •Cardiac T2* score >20 msec within 6 months before Baseline (Day 1)
- •Willing to use contraception during the study
排除标准
- •Pregnant or breast-feeding
- •Serum creatinine greater than the upper limit of normal
- •Platelet count <100 × 10^9/L
- •Use of another investigational drug within the last 30 days
- •Significant cardiac, renal, hepatic dysfunction or other clinically significant conditions that, in the opinion of the Investigator, would exclude the subject
研究组 & 干预措施
12 mg/kg
Experimental
12 mg/kg SP-420 once daily for 14 days
干预措施: SP-420 (Drug)
24 mg/kg
Experimental
24 mg/kg SP-420 once daily for 28 days
干预措施: SP-420 (Drug)
9 mg/kg
Experimental
9 mg/kg SP-420 twice daily for 28 days
干预措施: SP-420 (Drug)
6 mg/kg
Experimental
6 mg/kg SP-420 once daily for 14 days
干预措施: SP-420 (Drug)
1.5 mg/kg
Experimental
1.5 mg/kg SP-420 once daily for 14 days
干预措施: SP-420 (Drug)
3 mg/kg
Experimental
3 mg/kg SP-420 once daily for 14 days
干预措施: SP-420 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Up to 35 days
次要结局
- Area under the plasma concentration versus time curve (AUC) of SP-420(Day 7)
- Peak Plasma Concentration (Cmax) of SP-420(Day 7)
研究者
研究点 (1)
Loading locations...
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