Health Condition 1: K701- Alcoholic hepatitis
Conditions
Interventions
Intervention1: mycophenolate mofetil: Intervention arm in the study will receive MMF at a dose of 750 mg twice daily for a period of 28 days.
Control Intervention1: Steroid prednisolone: Oral steroid
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of MMF versus steroid therapy in improving short-term (28 day) survival outcomes in patients with alcoholic hepatitisTimepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the impact of MMF versus steroid therapy on disease severity in patients with alcoholic hepatitis at 28 days and 90 daysTimepoint: 28 & 90 days;To investigate the safety profile of MMF versus steroid therapy in patients with alcoholic hepatitis, including adverse events and tolerability.Timepoint: 28 & 90 days;To compare the efficacy of MMF versus steroid therapy in improving long-term (90 day) survival outcomes in patients with alcoholic hepatitisTimepoint: 28 & 90 days;To see molecular biomarkers like Interleukin (IL 6), Interleukin(IL 1) and their response to both the therapies.Timepoint: 28 & 90 days | — |
Countries
India
Contacts
Public ContactDr Shasthry S M
Institute of Liver and Biliary Sciences
Outcome results
None listed