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

• Status: Completed
• Trial end date: 2008-08-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Rifamycins; Rifaximin

Criteria

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