Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy
NCT ID: NCT01846663
Last Updated: 2024-01-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
6 participants
INTERVENTIONAL
2013-04-03
2016-02-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rifaximin
Rifaximin, oral, 550 mg BID, 6 months of treatment
Rifaximin
Rifaximin, oral, 550 mg BID, 6 months treatment
Placebo
Placebo, oral, 0 mg BID, 6 months of treatment
Placebo
Placebo, oral, 0 mg BID, 6 months of treatment
Interventions
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Placebo
Placebo, oral, 0 mg BID, 6 months of treatment
Rifaximin
Rifaximin, oral, 550 mg BID, 6 months treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
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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Varsha Bhatt, Ph.D.
Role: STUDY_DIRECTOR
Bausch Health Americas, Inc.
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner Research
Phoenix, Arizona, United States
University Of Arizona Liver Research Institute
Tucson, Arizona, United States
Southern California Liver Centers
Coronado, California, United States
UCSD Clinical & Translational Research Institute
La Jolla, California, United States
Loma Linda University Medical Center Transplantation Institute
Loma Linda, California, United States
University of Southern Califorina Keck School Of Medicine
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Salix Site
New Haven, Connecticut, United States
Salix Site
Tampa, Florida, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Northwestern University-Comprehensive Transplant Center
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Tulane Abdominal Transplant Research Office
New Orleans, Louisiana, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
New York University School of Medicine
New York, New York, United States
Salix Site
Portland, Oregon, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States
Brook Army Medical Center
Fort Sam Houston, Texas, United States
Salix Site
Galveston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
McGuire VA Medical Center
Richmond, Virginia, United States
VCU/MCV Health Systems
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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RFHE4043
Identifier Type: -
Identifier Source: org_study_id
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