Rifaximin Use in Severe Alcoholic Hepatitis

June 25, 2015 updated by: Do Seon Song, Saint Vincent's Hospital, Korea

Effect of Gut Decontamination Using Rifaximin in the Patients With Severe Alcoholic Hepatitis

This study aimed to investigate the effect of decontamination by rifaximin in severe alcoholic hepatitis patients. Patients who take corticosteroid or pentoxifylline will be randomly allocated to rifaximin group or control group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Heavy alcohol drinking within 3 months (Over 40 g/day)
  • Maddrey's discriminant function ≥ 32
  • AST/ALT ration ≥ 2
  • Bilirubin level ≥ 5mg/dL
  • Any one of the following additional criteria : hepatic encephalopathy, enlarged, tender liver, or peripheral leucocytosis
  • Age : 19-75
  • Jaundice within 3 months

Exclusion Criteria:

  • Other causes of chronic liver disease (HBV, HCV, or autoimmune hepatitis)
  • Antibiotics or probiotics use within 8 weeks
  • Drug induced hepatotoxicity
  • Acute viral hepatitis (HAV or HEV)
  • Hepatic abscess or cholagitis
  • Hepatocellular carcinoma of modified UICC stage II, III or IV
  • Malignant tumor other than HCC
  • Pregnancy
  • Severe chronic extrahepatic disease
  • Type I hepatorenal syndrome
  • Hepatic encephalopathy grade II or IV
  • Severe infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rifaximin group
Corticosteroid or Pentoxifylline for 28 days Rifaximin 400mg tid for 28 days
Drug: Rifaximin
400mg three times per day for 28 days
Drug: Corticosteroid or pentoxifylline
Corticosteroid 40mg/day or pentoxifylline 400mg three times per day for 28 days
Active Comparator: Control group
Corticosteroid or Pentoxifylline for 28 days
Drug: Corticosteroid or pentoxifylline
Corticosteroid 40mg/day or pentoxifylline 400mg three times per day for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 6-month
6-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Vincent's Hospital, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Estimate)

June 30, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDS-SAH-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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