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

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Jan 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for people with alcoholic hepatitis, a serious liver condition caused by heavy drinking. The researchers want to compare the effects of a medication called Mycophenolate mofetil with standard steroid therapy. They will include adults aged 18 to 70 who meet specific health criteria, such as having a certain score related to liver function (called MELD score) between 20 and 35. Participants will be divided into two groups: one will receive Mycophenolate mofetil, and the other will receive steroids. Both groups will be monitored for 90 days to see how well the treatments work and to check for any side effects.

If you or a family member are interested, it’s important to know that this trial is not yet recruiting participants, and there are certain health conditions that would exclude someone from joining, such as serious infections or other significant health issues. Throughout the study, participants will have regular assessments to track their health and any changes in their condition. The goal is to find out which treatment helps improve survival and liver health better in patients with alcoholic hepatitis.

Gender

ALL

Eligibility 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:
• • 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.