Rifaximin Use in Severe Alcoholic Hepatitis

S

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)

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

Trial contacts and locations

0

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Central trial contact

Do Seon Song

Data sourced from clinicaltrials.gov

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