Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Hepatic Encephalopathy

In brief

The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.

Key facts

Study ID

NCT01846663

Run by

Bausch Health Americas, Inc.

People needed

6

Starts

2013-04-03

Expected to finish

2016-02-22

Last updated by the study team

2024-01-09

Who can join

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

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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