Study Results
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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UNKNOWN
PHASE3
170 participants
INTERVENTIONAL
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rifaximin group
Corticosteroid or Pentoxifylline for 28 days Rifaximin 400mg tid for 28 days
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
Control group
Corticosteroid or Pentoxifylline for 28 days
Corticosteroid or pentoxifylline
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
Corticosteroid or pentoxifylline
Corticosteroid 40mg/day or pentoxifylline 400mg three times per day for 28 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
75 Years
ALL
No
Sponsors
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Saint Vincent's Hospital, Korea
OTHER
Responsible Party
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Do Seon Song
Clinical assistant professor
Central Contacts
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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.
Other Identifiers
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SDS-SAH-001
Identifier Type: -
Identifier Source: org_study_id