Rifaximin Use in Severe Alcoholic Hepatitis

Saint Vincent's Hospital, Korea

Status and phase: Unknown; Phase 3

Conditions: Severe Alcoholic Hepatitis

Treatments: Drug: Corticosteroid or pentoxifylline; Drug: Rifaximin

Study type: Interventional

Funder types: Other

Identifiers

NCT02485106

SDS-SAH-001

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Rifaximin group

Active Comparator group

Description:

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

Treatment:

Drug: Rifaximin

Drug: Corticosteroid or pentoxifylline

Control group

Active Comparator group

Description:

Corticosteroid or Pentoxifylline for 28 days

Treatment:

Drug: Corticosteroid or pentoxifylline