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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.
Study Design: Single-center, randomized control trial of 1 year duration.
Aim and Objective - To compare the efficacy and safety of Mycophenolate Mofetil (MMF) versus steroid therapy for the treatment of alcoholic hepatitis.
Hypothesis -
- MMF as a first line agent maybe associated with better 28 day and 90-day survival without increasing the risk of infection.
Study population: Patients > 18 years of age.Who are diagnosed as Alcoholic hepatitis based on NIAAA criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mycophenolate mofetil | Experimental | Intervention arm in the study will receive MMF at a dose of 750 mg twice daily for a period of 28 days. |
|
| Steroid prednisolone | Active Comparator | steroid at a dose of 40 mg for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate Mofetil | Drug | MMF at a dose of 750 mg twice daily for a period of 28 days, |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the efficacy of MMF versus steroid therapy in improving short-term (28 day) survival outcomes in patients with alcoholic hepatitis | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| MDF Score in alcoholic hepatitis in both the groups at 28 days and 90 days. | 28 days and 90 days. | |
| Number of patients with adverse events in both the groups. | 28 days and 90 days. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Ananthu Narayan, MD | Contact | 01146300000 | ananthunarayansj@gmail.com | |
| Dr Shasthry SM, DM | Contact | 01146300000 | shasthry@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| ID | Term |
|---|---|
| D006519 | Hepatitis, Alcoholic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Prednisone | Drug | Prednisone at a dose of 40 mg for 28 days. |
|
| To compare the efficacy of MMF versus steroid therapy in improving long-term (90 day) survival outcomes in patients with alcoholic hepatitis |
| 28 days and 90 days. |
| To see molecular biomarkers like Interleukin (IL 6), Interleukin(IL 1) and their response to both the therapies. | 28 days and 90 days. |
| D020751 |
| Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |