A 6-month Efficacy, Safety, and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-19

Study Completion Date

2008-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine if the study drug is safe and effective in preventing hepatic encephalopathy (HE).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01842581

Hepatic Encephalopathy Cirrhosis

COMPLETED PHASE4

Randomised Controlled Trial of Mechanistic Effects of Rifaximin in Cirrhosis and Chronic Hepatic Encephalopathy

NCT02019784

Liver Cirrhosis Hepatoencephalopathy, Early Fatal Progressive

COMPLETED PHASE4

Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis

NCT05297448

Hepatic Encephalopathy

ACTIVE_NOT_RECRUITING PHASE3

Rifaximin Modify the Pathogenesis of Non-Alcoholic Fatty Liver Disease (NAFLD)

NCT02884037

Non-alcoholic Fatty Liver Disease

COMPLETED

Efficacy of Rifaximin on Hepatosteatosis and Steatohepatitis Patients

NCT02009592

Fatty Liver Steatohepatitis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatic Encephalopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rifaximin

Participants were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for 6 months or until a breakthrough episode of hepatic encephalopathy or another reason for discontinuation.

Group Type EXPERIMENTAL

Rifaximin

Intervention Type DRUG

Oral

Placebo

Participants were administered a single matching placebo tablet 2 times per day (approximately every 12 hours) for 6 months or until a breakthrough episode of hepatic encephalopathy or another reason for discontinuation.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rifaximin

Oral

Intervention Type DRUG

Placebo

Oral

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Xifaxan®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Must sign an Informed Consent Form
* In remission from past HE
* Uses appropriate birth control measures
* More than or equal to 18 years of age
* Must have potential to benefit from treatment
* Recent prior HE episodes
* Capable and willing to comply with all study procedures
* Participant has personal support available
* Has a certain Model End Stage Liver Disease (MELD) score
* Recent transjugular intrahepatic portosystemic shunt (TIPS) placement or revision

Exclusion Criteria

* Significant medical conditions, medical conditions that may impact study participation, or Investigator decision not to include
* Allergies to the study drug or similar drugs
* Laboratory abnormalities
* Recent participation in another clinical trial
* History of non-compliance
* Pregnant or at risk of pregnancy, or is lactating
* Recent alcohol consumption
* Active bacterial or viral Infections
* Bowel issues
* Active malignancy
* On a prohibited medication
* Liver transplant expected in near term
* Lactulose intolerance
* Participant shows presence of intestinal obstruction or has inflammatory bowel disease
* Ongoing or recent GI bleed

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No