Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Hepatic Encephalopathy

Treatments: Drug: Rifaximin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00686920

RFHE3002

Details and patient eligibility

About

This study will look at the safety of a drug used in participants who have had hepatic encephalopathy (HE) in the past.

Full description

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.

Enrollment: 322 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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322 participants in 1 patient group

Rifaximin

Experimental group

Description:

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.

Treatment:

Drug: Rifaximin