Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy
A Multi-Center, Open-Label Trial to Evaluate the Long-Term Safety and Tolerability of Rifaximin 550 mg BID in Subjects With a History of Hepatic Encephalopathy
1 other identifier
interventional
322
2 countries
35
Brief Summary
This study will look at the safety of a drug used in participants who have had hepatic encephalopathy (HE) in the past.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2007
Typical duration for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 7, 2007
CompletedFirst Submitted
Initial submission to the registry
May 27, 2008
CompletedFirst Posted
Study publicly available on registry
May 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2010
CompletedResults Posted
Study results publicly available
August 14, 2019
CompletedAugust 14, 2019
July 1, 2019
3.8 years
May 27, 2008
July 19, 2019
July 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number Of Participants Reporting A Non-serious Adverse Event Or A Serious Adverse Event
A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Baseline up to Month 36
Secondary Outcomes (3)
Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants
Baseline up to Month 36
Number Of Participants With A Significant Mean Change From Baseline In Vital Signs
Baseline up to Month 36
Change From Baseline In Conn Score At Last Assessment
Baseline up to Month 36
Study Arms (1)
Rifaximin
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Aurora, California, United States
Unknown Facility
Fresno, California, United States
Unknown Facility
La Jolla, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Merced, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Golden, Colorado, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Macon, Georgia, United States
Unknown Facility
Iowa City, Iowa, United States
Unknown Facility
Monroe, Louisiana, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Lebanon, New Hampshire, United States
Unknown Facility
Bayside, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Asheville, North Carolina, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Odessa, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Madison, Wisconsin, United States
Unknown Facility
Calgary, Alberta, Canada
Unknown Facility
Victoria, British Columbia, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Montreal, Quebec, Canada
Related Publications (2)
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.
PMID: 37467180DERIVEDMullen 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.
PMID: 24365449DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Operations
- Organization
- Bausch Health Companies
Study Officials
- STUDY DIRECTOR
Lindsey Mathew
Bausch Health Companies
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2008
First Posted
May 30, 2008
Study Start
March 7, 2007
Primary Completion
December 8, 2010
Study Completion
December 8, 2010
Last Updated
August 14, 2019
Results First Posted
August 14, 2019
Record last verified: 2019-07