A Multi-Center, Open-Label Trial to Evaluate the Long-Term Safety and Tolerability of Rifaximin 550 mg BID in Subjects With a History of Hepatic Encephalopathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 322
- 主要终点
- Number Of Participants Reporting A Non-serious Adverse Event Or A Serious Adverse Event
研究概览
简要总结
This study will look at the safety of a drug used in participants who have had hepatic encephalopathy (HE) in the past.
详细描述
Eligible participants had a history of HE, a Conn score of 0 to 2 at enrollment, and either had successfully participated in a previous HE study with rifaximin (that is, RFHE3001 [NCT00298038]), or were new participants enrolled with ≥1 verifiable episode of HE (equivalent to a Conn score of ≥2) associated with cirrhosis or portal hypertension within 12 months of screening.
Successful participation in a previous rifaximin study was defined as having received ≥80% and ≤120% of the expected tablets, having been reasonably compliant with study procedures, and having not been discontinued from the previous study due to study drug-related Adverse Events. Participants who experienced HE or associated symptoms during or after the RFHE3001 study were considered eligible for entry into this open-label study if the participant and Investigator did not perceive study medication as a possible cause of the HE episode or associated symptoms. Participants who did not participate in a previous HE study with rifaximin were eligible if this open-label study was the only rifaximin HE study available at an individual site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Appropriate birth control measures
- •More than or equal to 18 years of age
- •Must be potential for benefit from treatment
- •Recent HE episodes
- •Capable and willing to comply with all study procedures
- •Participant has support network
排除标准
- •Significant medical conditions or Investigator decision not to include the participant
- •Allergies to the study drug or similar drugs
- •Laboratory abnormalities
- •Recent participation in another clinical trial
- •Problems experienced in a previous HE trial
- •Pregnant or at risk of pregnancy
- •Recent alcohol consumption
- •Active or latent bacterial or viral Infections
- •Bowel issues
- •Recent Active Cancer
- •On a prohibited medication
研究组 & 干预措施
Rifaximin
Participants from a previous rifaximin HE study and new participants were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
干预措施: Rifaximin (Drug)
结局指标
主要结局
Number Of Participants Reporting A Non-serious Adverse Event Or A Serious Adverse Event
时间窗: Baseline up to Month 36
A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
次要结局
- Number Of Participants With A Significant Mean Change From Baseline In Vital Signs(Baseline up to Month 36)
- Change From Baseline In Conn Score At Last Assessment(Baseline up to Month 36)
- Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants(Baseline up to Month 36)