The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy

Completed · Phase 4

Conditions studied: Hepatic Encephalopathy, Cirrhosis

In brief

The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.

Key facts

Study ID

NCT01842581

Run by

Bausch Health Americas, Inc.

People needed

222

Starts

2013-01-08

Expected to finish

2014-12-17

Last updated by the study team

2019-09-09

Who can join

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

You may qualify if…

• Male or non-pregnant, non-lactating females greater than or equal to (≥) 18 years old.
• In remission from demonstrated overt HE (Conn score 0 or 1).
• Have had one or more episodes of overt HE associated with cirrhosis within 6 months prior to screening visit (Day -7 to -1).
• Participant has a close family member or other personal contact who is familiar with the participant's HE and can provide continuing oversight to the participant and is willing to perform as caregiver for the participant during the conduct of the trial.

You may not qualify if…

• Participant has been diagnosed with human immunodeficiency virus (HIV) as determined by medical history.
• History of tuberculosis infection.
• Participant has been diagnosed with chronic respiratory insufficiency.
• Participant has been diagnosed with a current infection for which they are currently taking oral or parenteral antibiotics.
• Renal insufficiency requiring routine dialysis.
• Participant has an active spontaneous bacterial peritonitis(SBP) infection.
• Intestinal obstruction or inflammatory bowel disease.
• Participant has active malignancy within the last 5 years prior to screening visit, except basal cell carcinoma of the skin, or if female, in situ cervical carcinoma that has been surgically excised.
• Current gastrointestinal (GI) bleeding or has a history of a GI hemorrhage of sufficient severity to require hospitalization and a transfusion of ≥2 units of blood within 3 months prior to screening visit.
• Participant is anemic, as defined by a hemoglobin of less than (<) 8 grams/deciliter (g/dL).
• Scheduled to receive a liver transplant within 1 month of screening.

Where it is running

• Banner Research — Phoenix, Arizona, United States
• Southern California Liver Centers — Coronado, California, United States
• UCSF/Fresno - CRMC — Fresno, California, United States
• UCSD Clinical & Translational Research Institute — La Jolla, California, United States
• Salix Site — Long Beach, California, United States
• Inland Empire Liver Foundation — Rialto, California, United States
• Salix Site — Riverside, California, United States
• Salix Site — San Diego, California, United States
• Salix Site — San Francisco, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• South Denver GI — Englewood, Colorado, United States
• University of Florida Hepatology — Gainesville, Florida, United States
• Tampa General Medical Group — Tampa, Florida, United States
• Gastroenterology Associates — Macon, Georgia, United States
• Salix Site — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Central Iowa Hospital Corp — Des Moines, Iowa, United States
• Salix Site — Jefferson, Louisiana, United States
• Delta Research Partners, LLC — Monroe, Louisiana, United States
• The Center for Liver and Biliary Disease — Baltimore, Maryland, United States
• Brigham and Women's Hospital Division of Gastroenterology & Hepatology — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Kansas City Research Institute — Kansas City, Missouri, United States
• St. Louis University — St Louis, Missouri, United States
• Univ. of Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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