NCT00102791终止3 期
A Phase III Multicenter, 52-Week, Randomized, Double-Blind, Placebo-Controlled Study of the Clinical Efficacy and Safety of ICA-17043 With or Without HU Therapy in Patients With Sickle Cell Disease Who Have Had =>2 Acute Sickle-Related Painful Crises Within the Preceding 12 Months
Icagen49 个研究点 分布在 6 个国家目标入组 297 人开始时间: 2005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
- 297
- 试验地点
- 49
- 主要终点
- Sickle Cell Crisis Rate
研究概览
简要总结
The purpose of this study is to compare the effects of ICA-17043 to placebo with or without hydroxyurea (an oral drug used for treatment of sickle cell disease) in patients with sickle cell disease who have had 2 or more acute sickle-related painful crises requiring a visit to a medical facility within the past 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 to 65 years of age (inclusive)
- •Male or female (not capable of becoming pregnant or using appropriate birth control)
- •Medical history of sickle cell disease
- •Have a history of at least two or more acute sickle-related painful crises requiring a visit to a medical facility within the preceding 12 months
排除标准
- •Hemoglobin <4 or >11 g/dL
- •On a chronic transfusion program
- •Has significant active and poorly controlled (unstable) cardiovascular, neurologic, endocrine, hepatic, or renal disorders clearly unrelated to sickle cell disease
结局指标
主要结局
Sickle Cell Crisis Rate
时间窗: 52 weeks
次要结局
- Health Economics(52 Weeks)
- Time to First, Second, and Third Crisis(52 Weeks)
- Maximum Crisis Morbidity Ranking(52 Weeks)
- Efficacy Related Laboratory Parameters(52 Weeks)
- Quality of Life(52 Weeks)
研究者
研究点 (49)
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