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

Completed · Phase 3

Conditions studied: Hepatic Encephalopathy

In brief

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

Key facts

Study ID

NCT00686920

Run by

Bausch Health Americas, Inc.

People needed

322

Starts

2007-03-07

Expected to finish

2010-12-08

Last updated by the study team

2019-08-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Aurora, California, United States
• Study site — Fresno, California, United States
• Study site — La Jolla, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Merced, California, United States
• Study site — Sacramento, California, United States
• Study site — San Francisco, California, United States
• Study site — Golden, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Macon, Georgia, United States
• Study site — Iowa City, Iowa, United States
• Study site — Monroe, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Kansas City, Missouri, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Bayside, New York, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Asheville, North Carolina, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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