Randomized Controlled Trial of Mycophenolate Mofetil Versus Steroid Therapy in Alcoholic Hepatitis

NCT06789315 · tracked via the Priya Life Science India tracker

Sponsor

Institute of Liver and Biliary Sciences, India

Phase

Not applicable

Started

2025-01-20

Last updated

2025-01-23

Condition(s) studied

Alcoholic Hepatitis

Investigational drug(s) / intervention(s)

Mycophenolate MofetilPrednisone

Mycophenolate Mofetil: MMF at a dose of 750 mg twice daily for a period of 28 days,

Prednisone: Prednisone at a dose of 40 mg for 28 days.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: 1. Adults aged 18-70 years. 2. Diagnosis of Alcoholic hepatitis based on NIAAA criteria 3. MELD 20-35 4. Willing to follow up Exclusion Criteria: 1. Patients with hepatic/ extra hepatic malignancies 2. Patients with contraindications to steroids 3. Patients who are critically ill and are admitted to the ICU 4. Patient who have severe extra hepatic organ failure 5. Patients who are HBsAg +, HIV+ 6. If female of childbearing potential: known pregnancy, or unwilling to practice anticontraceptive measures 7. Patients who are on current treatment with prednisone and/or immunosuppressive me.

Primary outcome measure(s)

To compare the efficacy of MMF versus steroid therapy in improving short-term (28 day) survival outcomes in patients with alcoholic hepatitis — 28 days

Trial sites (1)

Facility	City	Region	Status
Institute of Liver & Biliary Sciences	New Delhi	National Capital Territory of Delhi

On this site

📄 Deltasone (prednisone) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06789315 on ClinicalTrials.gov ↗ ← All trials in India