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The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

A Multicenter, Randomized, Open-Label, Active-Controlled, Trial to Evaluate the Safety and Efficacy of Rifaximin 550 mg With and Without Lactulose in Subjects With a History of Recurrent Overt Hepatic Encephalopathy

NCT01842581•Bausch Health Americas, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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).
+1 more criteria

Locations (43)

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

Key Dates

Start Date

January 8, 2013

Primary Completion Date

December 17, 2014

Completion Date

December 17, 2014

Last Updated

September 9, 2019

Enrollment

222

ACTUAL participants

Conditions

Hepatic EncephalopathyCirrhosis

Interventions

Rifaximin

DRUG

Lactulose

DRUG

EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 9, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.

Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias

Mechanism of TIPS to Improve Sarcopenia

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation