NCT00364689终止3 期
RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Number of Hospitalizations for Hepatic Encephalopathy (HE)
研究概览
简要总结
The purpose of this study is to compare the effectiveness of three different treatments for 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
- Double
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
- •Cirrhosis of any cause
- •History of previous admission for acute HE within 12 months of screening and Conn grade 0-1 HE at time of enrollment
- •An Institutional Review Board (IRB/EC) approved informed consent is signed and dated prior to any study-related activities being initiated.
- •Subject is a male or a non-pregnant and non-lactating female. Women of non-childbearing potential or who are practicing adequate birth control are eligible. The investigator is responsible for determining whether the subject has adequate birth control for study participation.
- •Subject is ≥18 years of age.
- •Subject is capable and willing to comply with all study procedures.
- •If the subject has a history of a portal-systemic shunt, shunt placement or revision must be >6 months from Screening for TIPS or a surgical shunt.
排除标准
- •Subject has a significant medical or psychiatric condition which, in the opinion of the Investigator, precludes participation in the study.
- •Subject has a history of allergy or intolerance to lactulose.
- •Subject has a history of allergy or intolerance to rifampin or rifaximin.
- •Subject has participated in an investigational drug or device study within the 30 days prior to study screening.
- •Subject is pregnant or is lactating.
- •Subject shows evidence of ongoing alcohol or drug dependence, in the opinion of the Investigator.
- •Subject has a visual impairment disorder (e.g., glaucoma, diabetic retinopathy, or macular degeneration) or a neurological disease beyond HE that, in the opinion of the Investigator, could impact their performance on neuropsychological assessments and psychometric tests.
- •Subject has any condition or circumstance that would, in the opinion of the Investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments or visits.
- •Subject's current, required medications are on prohibited concurrent medication listing.
- •Hemoglobin < 8.0 at time of screening
- •Severe hypovolemia or electrolyte abnormalities that would be likely to affect mental function (serum sodium less than 120 mEq/L, serum calcium greater than 11 mg/dL) at time of screening
- •Ongoing gastrointestinal bleeding at time of screening
- •Chronic renal insufficiency with a serum creatinine > 3.0 at time of screening
- •History of tuberculosis infection
研究组 & 干预措施
lactulose given with a placebo (sugar pill)
Experimental
干预措施: Lactulose (Drug)
lactulose given with a placebo (sugar pill)
Experimental
干预措施: Placebo (Other)
lactulose given with rifaximin
Experimental
干预措施: Rifaximin (Drug)
lactulose given with rifaximin
Experimental
干预措施: Lactulose (Drug)
rifaximin given alone
Active Comparator
干预措施: Rifaximin (Drug)
结局指标
主要结局
Number of Hospitalizations for Hepatic Encephalopathy (HE)
时间窗: Month 7
Changes in Psychometric Testing During Study Period
时间窗: Month 7
次要结局
- Number of Hospitalization Days for All Causes(Month 7)
- Death or Survival to Liver Transplantation(Month 7)
- Rate of Adverse Events With Rifaximin Treatment(Month 7)
研究者
研究点 (1)
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