Rifaximin Use in Severe Alcoholic Hepatitis

NCT ID: NCT02485106

Last Updated: 2015-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Brief Summary

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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

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Conditions

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Severe Alcoholic Hepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rifaximin group

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

Group Type ACTIVE_COMPARATOR

Rifaximin

Intervention Type DRUG

400mg three times per day for 28 days

Corticosteroid or pentoxifylline

Intervention Type DRUG

Corticosteroid 40mg/day or pentoxifylline 400mg three times per day for 28 days

Control group

Corticosteroid or Pentoxifylline for 28 days

Group Type ACTIVE_COMPARATOR

Corticosteroid or pentoxifylline

Intervention Type DRUG

Corticosteroid 40mg/day or pentoxifylline 400mg three times per day for 28 days

Interventions

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Rifaximin

400mg three times per day for 28 days

Intervention Type DRUG

Corticosteroid or pentoxifylline

Corticosteroid 40mg/day or pentoxifylline 400mg three times per day for 28 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint Vincent's Hospital, Korea

OTHER

Sponsor Role lead

Responsible Party

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Do Seon Song

Clinical assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Do Seon Song

Role: CONTACT

Phone: 82-31-249-8204

Email: [email protected]

References

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Song DS, Yang JM, Jung YK, Yim HJ, Kim HY, Kim CW, Kim SS, Cheong JY, Lee HL, Lee SW, Yoo JJ, Kim SG, Kim YS. Rifaximin treatment in patients with severe alcohol-associated hepatitis: A multicenter, randomized controlled, open-label, pilot trial. Ann Hepatol. 2025 Jan-Jun;30(1):101749. doi: 10.1016/j.aohep.2024.101749. Epub 2024 Dec 9.

Reference Type DERIVED
PMID: 39662593 (View on PubMed)

Other Identifiers

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SDS-SAH-001

Identifier Type: -

Identifier Source: org_study_id