Rifaximin Use in Severe Alcoholic Hepatitis

Phase 3

• Conditions: Severe Alcoholic Hepatitis
• Interventions: Drug: Corticosteroid or pentoxifylline; Drug: Rifaximin

• Registration Number: NCT02485106
• Lead Sponsor: Saint Vincent's Hospital, Korea

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-06
• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-06-25
• Last Update Submitted: 2015-06-25
• Study First Posted: 2015-06-30
• Last Update Posted: 2015-06-30
• Study Start: 2015-07
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Corticosteroid or pentoxifylline	Corticosteroid or Pentoxifylline for 28 days
Rifaximin group	Corticosteroid or pentoxifylline	Corticosteroid or Pentoxifylline for 28 days Rifaximin 400mg tid for 28 days
Rifaximin group	Rifaximin	Corticosteroid or Pentoxifylline for 28 days Rifaximin 400mg tid for 28 days

Primary Outcome Measures

Name	Time	Method
Mortality	6-month