Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy
Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy
This study will look at the safety of a drug used in participants who have had hepatic
 encephalopathy (HE) in the past.
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.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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