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NCT02485106
Effect of Gut Decontamination Using Rifaximin in the Patients With Severe Alcoholic Hepatitis
Phase 3 trial testing Rifaximin in Severe Alcoholic Hepatitis in 170 participants. Status unknown.
1 December 2016
Quick facts
| Lead sponsor | Saint Vincent's Hospital, Korea |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 170 |
| Start date | 1 July 2015 |
| Primary completion | 1 December 2016 |
Drugs / interventions tested
- Rifaximin (rifaximin) — full drug profile →
- Corticosteroid or pentoxifylline — full drug profile →
Conditions studied
- Severe Alcoholic Hepatitis — all drugs for Severe Alcoholic Hepatitis →
Sponsor
Saint Vincent's Hospital, Korea
Who can join
Adults 19 to 75, any sex, with Severe Alcoholic Hepatitis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Mortality
Time frame: 6-month
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Promises of microbiome-based therapies.
Bajaj JS, Ng SC, Schnabl B. · · 2022 · cited 79× · PMID 35589257 · DOI 10.1016/j.jhep.2021.12.003 -
Management of decompensated cirrhosis.
Mansour D, McPherson S. · · 2018 · cited 74× · PMID 29700095 · DOI 10.7861/clinmedicine.18-2-s60 -
Gut-liver axis and sterile signals in the development of alcoholic liver disease.
Szabo G, Petrasek J. · · 2017 · cited 56× · PMID 28482064 · DOI 10.1093/alcalc/agx025 -
Treatment of Severe Alcoholic Hepatitis.
Thursz M, Morgan TR. · · 2016 · cited 53× · PMID 26948886 · DOI 10.1053/j.gastro.2016.02.074 -
Gut microbiota-modulating agents in alcoholic liver disease: Links between host metabolism and gut microbiota.
Jung JH, Kim SE, Suk KT, Kim DJ. · · 2022 · cited 23× · PMID 35935787 · DOI 10.3389/fmed.2022.913842 -
Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis.
Zacharias HD, Kamel F, Kamel F, Tan J, et al · · 2023 · cited 22× · PMID 37467180 · DOI 10.1002/14651858.cd011585.pub2 -
Alcohol-Related Liver Disease: An Overview on Pathophysiology, Diagnosis and Therapeutic Perspectives.
Ha Y, Jeong I, Kim TH. · · 2022 · cited 19× · PMID 36289791 · DOI 10.3390/biomedicines10102530 -
Emerging medical therapies for severe alcoholic hepatitis.
Tornai D, Szabo G. · · 2020 · cited 19× · PMID 32981291 · DOI 10.3350/cmh.2020.0145
Verify or expand the search:
- PubMed search for NCT02485106
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Rifaximin
Trials testing the same drug.
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- NCT07203846 — Modulation of Gut MicroFLORA With Rifaximin to Reduce High Platelet Reactivity in Post-ACS Patients on Ticagrelor · Phase 4 · not yet recruiting
- NCT06483737 — Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE) · NA · recruiting
- NCT06808009 — Goal Directed Ammonia Lowering Therapy in Hyperammonemic ACLF Patients With no Overt HE to Reduce Major Adverse Liver Re · NA · not yet recruiting
- NCT06652087 — Rifaximin and Cardiac Function in Patients with Heart Failure with Preserved Ejection Fraction · NA · recruiting
Other Saint Vincent's Hospital, Korea trials
Trials by the same sponsor.
- NCT07045623 — Comparison of Intensive Versus Standard Care & Education for Dyslipidemia in Hypertension and Diabetes Patients · NA · recruiting
- NCT06756828 — Effects of 3-Month Melatonin Treatment on Regional Cerebellar Structure and Blood Biomarkers in Alzheimer's Disease Spec · NA · not yet recruiting
- NCT06477562 — Surveillance Endoscopy After Proximal Gastriectomy With Double Tract Reconstruction. · completed
- NCT06186037 — Clinical Comparison of Low-dose Rosuvastatin Plus Ezetimibe Combination Therapy and High-dose Rosuvastatin Monotherapy i · Phase 4 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02485106 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Saint Vincent's Hospital, Korea
- Last refreshed: 25 June 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02485106.
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