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

• Status: Completed
• Trial end date: 2010-12-08
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

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

Criteria

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