A Prospective, Open-Label, Single-Arm, Pilot Study To Evaluate The Effectiveness Of Oral Ademetionine In Patients With Alcoholic Liver Disease (ALD) In Indian Scenario (ADEM-D22-0319)

The study population will include out-patients with alcoholic liver disease inclusive of fatty liver, alcoholic hepatitis, and alcoholic cirrhosis, visiting the Institute Of Liver Gastroenterology and Pancreatico Biliary Sciences, Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi 110 060, India; and are clinically indicated for the treatment with ademetionine tablets, as per the discretion of the investigator. It is expected that approximately 50 patients will be enrolled in this pilot study.  The patients will be prescribed ademetionine oral tablets at a total daily dose of 1200 mg (400 mg tablet ─three times a day), for the period of Four (4)-weeks, to be taken with water and not with the meal,as per the discretion of the investigator. The patients will be followed up for 28 days after enrollment into the study.

The selection of patients for the study will be totally at the discretion of the investigator. All patients diagnosed with alcoholic liver disease (ALD) inclusive of fatty liver, alcoholic hepatitis, and alcoholic cirrhosis,meeting inclusion and exclusion criteria, and ready to give informed consent for study participation, are eligible for participation in this study.

At the screening visit (Visit 1 [Day -3]), informed consent will be taken, before assessing the patient’s eligibility and entry into the study. Demographic details- age, and gender will be captured; and clinical examination, which will include a record of vitals (including blood pressure (BP), pulse rate (PR), respiratory rate (RR), and body temperature), physical and systemic examination, will be done. Detailed medical history (including duration of disease, present treatment regime, co-existing condition, etc.) will be taken. The data for serum laboratory investigations which will include liver function tests (LFT) (AST, ALT, ALP, AST: ALT ratio, GGT, STB, and SCB), Lipid profile tests (low-density lipoprotein, high-density lipoprotein, very low-density lipoprotein, total cholesterol, triglycerides, total cholesterol/HDL cholesterol ratio), international normalized ratio (INR)  and serum creatinine test; and radiology investigations, if available, which may include fibroscan and ultrasonography findings, will be collated from patients medical history and/or lab-investigation records. Patients will be required to undergo serum laboratory investigations (TNF-α).

At baseline (Visit 2 [Day 0]), the patient’s eligibility and entry into the study will be evaluated based on serum laboratory and radiology investigations reports and inclusion and exclusion criteria. Patients fulfilling all of the inclusion and violating none of the exclusion criteria will be enrolled in the study. Patients will be prescribed ademetionine at a total daily dose of 1200 mg orally (400 mg tablet ─ three times a day), for the period of Four (4)-weeks, to be taken with water and not with the meal.

Progress made by the patient will be reviewed on Days 14 and 28.  All patients will be followed up appropriately so the results of altering the independent variable (intervention) may be analyzed. Every effort will be made to contact patients who were lost to follow-up and reengage them in the study.