NCT00867698已完成2 期
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy, Safety and Tolerability of AST-120 (Spherical Carbon Adsorbent) for 8 Weeks in the Treatment of Mild Hepatic Encephalopathy
Ocera Therapeutics37 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 37
- 主要终点
- Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline.
研究概览
简要总结
The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed cirrhosis of any cause
- •Abnormal RBANS global summary score
- •Grade 0 or 1 hepatic encephalopathy by West-Haven Scale
- •MELD score < or = 25
- •Females must be postmenopausal, surgically incapable of bearing children or practicing a reliable method of birth control
排除标准
- •Previous participation in any trial involving AST-120
- •History of TIPS or surgically created portocaval shunt
- •Treatment for overt HE within the past 3 months
- •Use of lactulose, rifaximin, neomycin or other antibiotics in the past 7 days
- •Active alcohol abuse
- •Psychosis or organic brain syndromes due to alcohol or other causes
- •Use of interferon and sedating or cognition-altering drugs
- •Undergoing chemotherapy or radiotherapy for the treatment of cancer
- •Active GI bleeding within the past 3 months
- •Presence of an active infection
- •Presence of signs and symptoms of severe dehydration
- •Other major physical or major psychiatric illness within the past 6 months
- •Pregnant, breast feeding, or planning to become pregnant during the study
- •Using hormonal contraception as the only method of birth control
研究组 & 干预措施
AST-120 (6g)
Experimental
2 grams TID
干预措施: AST-120 (Drug)
Placebo A
Placebo Comparator
2 grams TID
干预措施: AST-120 (Drug)
AST-120 (12g)
Experimental
4 grams TID
干预措施: AST-120 (Drug)
Placebo B
Placebo Comparator
4 grams TID
干预措施: AST-120 (Drug)
结局指标
主要结局
Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline.
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (37)
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