Severe Alcoholic HepatitisPhase 3NCT02485106
Rifaximin Use in Severe Alcoholic Hepatitis
A Phase 3 study testing Rifaximin and Corticosteroid or pentoxifylline in people with Severe Alcoholic Hepatitis, run by Saint Vincent's Hospital, Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Severe Alcoholic Hepatitis
- What is being tested?
- Rifaximin and Corticosteroid or pentoxifylline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- Malignant tumor other than HCC
- Pregnancy
- Severe chronic extrahepatic disease
- Type I hepatorenal syndrome
- Hepatic encephalopathy grade II or IV
- Severe infection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Gut Decontamination Using Rifaximin in the Patients With Severe Alcoholic Hepatitis
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.
- Conditions
- Severe Alcoholic Hepatitis
- Being tested
- Rifaximin, Corticosteroid or pentoxifylline
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
400mg three times per day for 28 days
Corticosteroid or pentoxifyllineDrug
Corticosteroid 40mg/day or pentoxifylline 400mg three times per day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin group | Active comparator | Corticosteroid or Pentoxifylline for 28 days Rifaximin 400mg tid for 28 days Receives: Drug: Rifaximin; Drug: Corticosteroid or pentoxifylline |
| Control group | Active comparator | Corticosteroid or Pentoxifylline for 28 days Receives: Drug: Corticosteroid or pentoxifylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Alcoholic HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Vincent's Hospital, Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do Seon Song, Saint Vincent's Hospital, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485106
- Sponsor's protocol ID
- SDS-SAH-001
- Status last verified
- Jun 2015
- First submitted
- 24 Jun 2015
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39662593
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gut Decontamination Using Rifaximin in the Patients With Severe Alcoholic Hepatitis
- ClinicalTrials.gov ID
- NCT02485106
- Acronym / sponsor ID
- SDS-SAH-001
- Conditions
- Severe Alcoholic Hepatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Saint Vincent's Hospital, KoreaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (estimated)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifaximin group | Active comparator | Drug: Rifaximin, Drug: Corticosteroid or pentoxifyllineCorticosteroid or Pentoxifylline for 28 days Rifaximin 400mg tid for 28 days |
| Control group | Active comparator | Drug: Corticosteroid or pentoxifyllineCorticosteroid or Pentoxifylline for 28 days |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifaximin400mg three times per day for 28 days | Drug | Rifaximin group |
| Corticosteroid or pentoxifyllineCorticosteroid 40mg/day or pentoxifylline 400mg three times per day for 28 days | Drug | Control group, Rifaximin group |
Primary outcome
Mortality
Time frame: 6-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
- Derived from this study: PubMed 39662593Song 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rifaximin and Corticosteroid or pentoxifylline in people with Severe Alcoholic Hepatitis, run by Saint Vincent's Hospital, Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Do Seon Song (82-31-249-8204, dsman@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02485106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2015.