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Rifaximin Use in Severe Alcoholic Hepatitis

Primary Purpose

Severe Alcoholic Hepatitis

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rifaximin
Corticosteroid or pentoxifylline
Sponsored by
Saint Vincent's Hospital, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Alcoholic Hepatitis

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Rifaximin group

    Control group

    Arm Description

    Corticosteroid or Pentoxifylline for 28 days Rifaximin 400mg tid for 28 days

    Corticosteroid or Pentoxifylline for 28 days

    Outcomes

    Primary Outcome Measures

    Mortality

    Secondary Outcome Measures

    Full Information

    First Posted
    June 24, 2015
    Last Updated
    June 25, 2015
    Sponsor
    Saint Vincent's Hospital, Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02485106
    Brief Title
    Rifaximin Use in Severe Alcoholic Hepatitis
    Official Title
    Effect of Gut Decontamination Using Rifaximin in the Patients With Severe Alcoholic Hepatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Saint Vincent's Hospital, Korea

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Severe Alcoholic Hepatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    170 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Rifaximin group
    Arm Type
    Active Comparator
    Arm Description
    Corticosteroid or Pentoxifylline for 28 days Rifaximin 400mg tid for 28 days
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Corticosteroid or Pentoxifylline for 28 days
    Intervention Type
    Drug
    Intervention Name(s)
    Rifaximin
    Intervention Description
    400mg three times per day for 28 days
    Intervention Type
    Drug
    Intervention Name(s)
    Corticosteroid or pentoxifylline
    Intervention Description
    Corticosteroid 40mg/day or pentoxifylline 400mg three times per day for 28 days
    Primary Outcome Measure Information:
    Title
    Mortality
    Time Frame
    6-month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Do Seon Song
    Phone
    82-31-249-8204
    Email
    dsman@catholic.ac.kr

    12. IPD Sharing Statement

    Learn more about this trial

    Rifaximin Use in Severe Alcoholic Hepatitis

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