NCT05071716进行中（未招募）3 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 524
- 试验地点
- 150
- 主要终点
- Time to first event of overt hepatic encephalopathy requiring medical intervention in hospital/ER/ED/clinic or death.
研究概览
简要总结
Study RNLC3131 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of liver cirrhosis with medically controlled ascites (>30 days) not requiring therapeutic paracentesis (could have had paracentesis in the past).
- •Conn (West Haven Criteria) score of <
- •Mini-Mental State Examination (MMSE) score > 24 at screening.
- •≥ 18 and ≤ 85 years of age.
排除标准
- •Active COVID-19 that is unresolved
- •History of SBP
- •History of EVB or AKI-HRS within 6 months
- •History of OHE episode (Conn score ≥ 2)
研究组 & 干预措施
Rifaximin SSD-40mg IR
Experimental
干预措施: Rifaximin SSD (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to first event of overt hepatic encephalopathy requiring medical intervention in hospital/ER/ED/clinic or death.
时间窗: 72 weeks
次要结局
- Time to first Conn score ≥ 2 or confirmed OHE requiring medical intervention in hospital/ER/ED/ clinic or death(72 weeks)
- Time to all-cause hospitalization(72 weeks)
- Time to first event of OHE that requires hospitalization, or all-cause death(72 weeks)
研究者
研究点 (150)
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