Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy
NCT ID: NCT00686920
Last Updated: 2019-08-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
322 participants
INTERVENTIONAL
2007-03-07
2010-12-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Rifaximin
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.
Rifaximin
Oral
Interventions
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Rifaximin
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lindsey Mathew
Role: STUDY_DIRECTOR
Bausch Health Companies
Locations
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Birmingham, Alabama, United States
Aurora, California, United States
Fresno, California, United States
La Jolla, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Merced, California, United States
Sacramento, California, United States
San Francisco, California, United States
Golden, Colorado, United States
Washington D.C., District of Columbia, United States
Macon, Georgia, United States
Iowa City, Iowa, United States
Monroe, Louisiana, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Kansas City, Missouri, United States
Lebanon, New Hampshire, United States
Bayside, New York, United States
New York, New York, United States
Rochester, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Odessa, Texas, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Madison, Wisconsin, United States
Calgary, Alberta, Canada
Victoria, British Columbia, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Countries
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References
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Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.
Mullen KD, Sanyal AJ, Bass NM, Poordad FF, Sheikh MY, Frederick RT, Bortey E, Forbes WP. Rifaximin is safe and well tolerated for long-term maintenance of remission from overt hepatic encephalopathy. Clin Gastroenterol Hepatol. 2014 Aug;12(8):1390-7.e2. doi: 10.1016/j.cgh.2013.12.021. Epub 2013 Dec 21.
Other Identifiers
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RFHE3002
Identifier Type: -
Identifier Source: org_study_id
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