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NCT06789315
Randomized Controlled Trial of Mycophenolate Mofetil Versus Steroid Therapy in Alcoholic Hepatitis
NA trial testing Mycophenolate Mofetil in Alcoholic Hepatitis in 60 participants. Not yet recruiting.
31 January 2026
Quick facts
| Lead sponsor | Institute of Liver and Biliary Sciences, India |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 20 January 2025 |
| Primary completion | 31 January 2026 |
| Estimated completion | 31 January 2026 |
| Sites | 1 location across India |
Drugs / interventions tested
- Mycophenolate Mofetil (MYCOPHENOLATE MOFETIL) — full drug profile →
- Prednisone (prednisone) — full drug profile →
Conditions studied
- Alcoholic Hepatitis — all drugs for Alcoholic Hepatitis →
Sponsor
Institute of Liver and Biliary Sciences, India
Who can join
Adults 18 to 70, any sex, with Alcoholic Hepatitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with acute alcoholic hepatitis will be identified based on national institute on alcohol abuse and alcoholism (NIAAA) will be identified, MELD score will be calculated, patents with MELD score between 20-35 will be randomized to two groups. Group A (intervention arm) will be receiving Mycofenolate mofetil at a dose of 750 mg twice daily and group B will be receiving steroid as per existing guidelines in a dose of 40 mg per day. Both the groups will be followed up for 90 days with assessment done at 4th, 7th and 28th day. Any significant event in addition will also be noted. Patients in group A will be also be monitored for development of complications like cytopenia due to Mycofenolate mofetil and infections will be monitored in both groups. Steroids will be stopped in the non-responders in group B based on Lille score at 4th and 7th day. The outcome variables of interest and to be measured are survival at 28 days and 90 days, clinical outcomes, including hospitalization and liver related outcomes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06789315
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Alcoholic Hepatitis
Currently open trials in the same condition.
- NCT06919458 — Short Course Steroids in Alcohol Associated Hepatitis · Phase 3 · recruiting
- NCT06307964 — Intra-Hepatic Microbiota in Alcoholic Hepatitis · recruiting
- NCT05006430 — Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis · Phase 1, PHASE2 · recruiting
- NCT05018481 — HA35 Moderate Alcoholic Hepatitis (AH) Study · EARLY_PHASE1 · recruiting
- NCT02473341 — Gut-Liver Axis Modulation With IgG-Enriched Immunotherapy in Severe Alcohol-Associated Hepatitis · Phase 3 · active not recruiting
Other Institute of Liver and Biliary Sciences, India trials
Trials by the same sponsor.
- NCT07480005 — To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies · recruiting
- NCT07480057 — Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry · recruiting
- NCT07465471 — Carvedilol and Midodrine Versus Carvedilol Alone in Preventing Early Rebleed in Patients With Cirrhosis. · NA · not yet recruiting
- NCT07433881 — Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis · not yet 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 NCT06789315 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Liver and Biliary Sciences, India
- Last refreshed: 23 January 2025
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/NCT06789315.
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