A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Rifaximin 550 mg BID For 6 Months In Preventing Hepatic Encephalopathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 299
- 主要终点
- Time To The First Breakthrough Overt HE Episode
研究概览
简要总结
The purpose of this study is to determine if the study drug is safe and effective in preventing hepatic encephalopathy (HE).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must sign an Informed Consent Form
- •In remission from past HE
- •Uses appropriate birth control measures
- •More than or equal to 18 years of age
- •Must have potential to benefit from treatment
- •Recent prior HE episodes
- •Capable and willing to comply with all study procedures
- •Participant has personal support available
- •Has a certain Model End Stage Liver Disease (MELD) score
- •Recent transjugular intrahepatic portosystemic shunt (TIPS) placement or revision
排除标准
- •Significant medical conditions, medical conditions that may impact study participation, or Investigator decision not to include
- •Allergies to the study drug or similar drugs
- •Laboratory abnormalities
- •Recent participation in another clinical trial
- •History of non-compliance
- •Pregnant or at risk of pregnancy, or is lactating
- •Recent alcohol consumption
- •Active bacterial or viral Infections
- •Bowel issues
- •Active malignancy
- •On a prohibited medication
- •Liver transplant expected in near term
- •Lactulose intolerance
- •Participant shows presence of intestinal obstruction or has inflammatory bowel disease
- •Ongoing or recent GI bleed
研究组 & 干预措施
Rifaximin
Participants were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for 6 months or until a breakthrough episode of hepatic encephalopathy or another reason for discontinuation.
干预措施: Rifaximin (Drug)
Placebo
Participants were administered a single matching placebo tablet 2 times per day (approximately every 12 hours) for 6 months or until a breakthrough episode of hepatic encephalopathy or another reason for discontinuation.
干预措施: Placebo (Drug)
结局指标
主要结局
Time To The First Breakthrough Overt HE Episode
时间窗: Baseline up to 6 Months (168 days)
Time to a breakthrough overt HE episode was the duration (number of days) from time of first dose of study drug to the first breakthrough overt HE episode. A breakthrough overt HE episode was defined as an increase of Conn score from Grade 0 or 1 to ≥2, or an increase in Conn and asterixis score of 1 grade each for those participants who entered the study with a Conn score of 0. Participants who completed the study and did not experience a breakthrough overt HE episode were censored at the time of their 6-month visit. Participants who terminated early for reasons other than a breakthrough overt HE episode were contacted at 6 months from randomization to determine if they had experienced a breakthrough overt HE event or other outcome. Participants without breakthrough overt HE were censored at the time of last contact or death, whichever was earlier. The number of events of a first breakthrough overt HE episode during the treatment interval is presented.
次要结局
- Time To First HE-related Hospitalization(Baseline up to 6 months)
- Time To Any Increase From Baseline In Conn Score(Baseline up to 6 months)
- Time To Any Increase From Baseline In Asterixis Grade(Baseline up to 6 months)
- Mean Change From Baseline In Fatigue Domain Score On The CLDQ At End Of Treatment(Baseline, 6 months (End Of Treatment))
- Mean Change From Baseline In Venous Ammonia Concentration At End Of Treatment(Baseline, Month 6 (End Of Treatment))