Rifaximin Use in Severe Alcoholic Hepatitis

Severe Alcoholic Hepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02485106
• Other study ID #: SDS-SAH-001
• Status: Not yet recruiting
• Phase: Phase 3
• First received: June 24, 2015
• Last updated: June 25, 2015
• Start date: July 2015

Study information

• Verified date: June 2015
• Source: Saint Vincent's Hospital, Korea
• Contact: Do Seon Song
• Phone: 82-31-249-8204
• Email: dsman[@]catholic.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 170
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic
• Severe Alcoholic Hepatitis

Intervention

Drug:
• Rifaximin
400mg three times per day for 28 days
• Corticosteroid or pentoxifylline
Corticosteroid 40mg/day or pentoxifylline 400mg three times per day for 28 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Saint Vincent's Hospital, Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		6-month	Yes