Study Stopped
Study was determined to be infeasible.
Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy, Safety, And Pharmacokinetics Of Rifaximin 550 Mg In Subjects With Severe Hepatic Impairment And Overt Hepatic Encephalopathy
1 other identifier
interventional
6
1 country
28
Brief Summary
The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2013
Typical duration for phase_4
28 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
April 3, 2013
CompletedFirst Submitted
Initial submission to the registry
April 24, 2013
CompletedFirst Posted
Study publicly available on registry
May 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2016
CompletedResults Posted
Study results publicly available
January 9, 2024
CompletedJanuary 9, 2024
January 1, 2024
2.9 years
April 24, 2013
December 15, 2023
January 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Participants With Hepatic Encephalopathy (HE) Breakthrough Episode
6 Months
Secondary Outcomes (1)
Proportion of Participants With HE-related Hospitalization
6 Months
Study Arms (2)
Rifaximin
EXPERIMENTALRifaximin, oral, 550 mg BID, 6 months of treatment
Placebo
PLACEBO COMPARATORPlacebo, oral, 0 mg BID, 6 months of treatment
Interventions
Eligibility Criteria
You may qualify if:
- Male or non-pregnant, non-breast feeding female ≥ 18 years old
- In remission from demonstrated overt HE
- Had ≥1 episode of overt HE associated with liver disease within the last 6 months
- MELD score of ≥ 19
- Has a close family member or other personal contact who is familiar with the subject's HE, can provide continuing oversight to the subject and is willing to be available to the subject during the conduct of the trial
You may not qualify if:
- HIV
- History of tuberculosis infection
- Chronic respiratory insufficiency
- Current infection and receiving antibiotics
- Renal insufficiency requiring dialysis
- Active spontaneous bacterial peritonitis infection
- Intestinal obstruction or has inflammatory bowel disease
- Active malignancy within the last 5 years
- Current GI bleeding or has had a GI hemorrhage within past 3 months
- Anemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
The University of Alabama at Birmingham
Birmingham, Alabama, 35294-0111, United States
Banner Research
Phoenix, Arizona, 85016, United States
University Of Arizona Liver Research Institute
Tucson, Arizona, 85724, United States
Southern California Liver Centers
Coronado, California, 92118, United States
UCSD Clinical & Translational Research Institute
La Jolla, California, 92037, United States
Loma Linda University Medical Center Transplantation Institute
Loma Linda, California, 92324, United States
University of Southern Califorina Keck School Of Medicine
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
Salix Site
New Haven, Connecticut, 06520, United States
Salix Site
Tampa, Florida, 33606, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309, United States
Northwestern University-Comprehensive Transplant Center
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Tulane Abdominal Transplant Research Office
New Orleans, Louisiana, 70112, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University
St Louis, Missouri, 63110, United States
New York University School of Medicine
New York, New York, 10016, United States
Salix Site
Portland, Oregon, 97239, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-1610, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
Brook Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Salix Site
Galveston, Texas, 77555, United States
The Methodist Hospital
Houston, Texas, 77030, United States
McGuire VA Medical Center
Richmond, Virginia, 23249, United States
VCU/MCV Health Systems
Richmond, Virginia, 23298, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Bausch Health Americas, Inc
Study Officials
- STUDY DIRECTOR
Varsha Bhatt, Ph.D.
Bausch Health Americas, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2013
First Posted
May 3, 2013
Study Start
April 3, 2013
Primary Completion
February 22, 2016
Study Completion
February 22, 2016
Last Updated
January 9, 2024
Results First Posted
January 9, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share