A 6-month Efficacy, Safety, and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Hepatic Encephalopathy

Treatments: Drug: Rifaximin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00298038

RFHE3001

Details and patient eligibility

About

The purpose of this study is to determine if the study drug is safe and effective in preventing hepatic encephalopathy (HE).

Enrollment: 299 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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299 participants in 2 patient groups, including a placebo group

Rifaximin

Experimental group

Description:

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.

Treatment:

Drug: Rifaximin

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo