Health Condition 1: K709- Alcoholic liver disease, unspecified
Conditions
Interventions
Intervention1: Ademetionine 400 mg Tablet: The patients will be
prescribed ademetionine oral tablets at a total daily dose of 1200 mg (400 mg tablet
â??three times a day), for the period of Four (4)-w
Sponsors
Dr Ashish Kumar
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients of either sex in the age group of 18-65 years. 2 Patients diagnosed with ALD inclusive of fatty liver, alcoholic hepatitis, and alcoholic cirrhosis as per physicianâ??s discretion based on patients medical history and/or lab investigation records. 3 Patient history that reliably indicates heavy alcohol use as assessed by the investigator for a minimum of 3 months before the screening date. (Heavy alcohol consumption [defined as greater than 40 ml per day on average in women and greater than 60 ml per day on average in men]) 4 Patients with ALT level greater than 2 times Upper Normal Limits (ULN) above normal range at the screening date. 5 Patients willing to participate in the study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients treated with any anticholestatic agent, Ursodeoxycholic Acid (UDCA), Obeticholic Acidï¼?OCA, and S-adenosylmethionine (SAMe) within the last 3 months of the screening date. 2. Patients with a history of consumption of steatogenic or cholestatic in the past 3 months before the screening date, that can impact the treatment outcomes as assessed by the investigator as per available records. 3. Patients with other causes of chronic liver disease (NAFLD, autoimmune liver diseases, viral hepatitis (Hepatitis B virus and Hepatitis C virus), Wilsonâ??s disease, hemochromatosis), and metabolic syndrome. 4. Patients with a history of severe liver disease such as with Child-Pugh Class B or C and with any end-stage liver disease. 5. Patients with a history of severe cardiac and renal disease (serum creatinine greater than 2.0 mg/dL) 6. Patients with a history of malignancy or active neoplasm 7. Patients with known genetic defects affecting the methionine cycle and/or causing homocystinuria and/or hyperhomocysteinemia (e.g., cystathionine beta-synthase deficiency, vitamin B12 metabolism defect) or known folate, vitamin B6 or B12 deficiency) 8. Pregnant and nursing women. 9. Women with childbearing potential not practicing a reliable method of birth control. 10. Patients with a known history of hypersensitivity to Ademetionine. 11 Suspected inability or unwillingness to comply with study procedures 12 Any other medical condition(s) or any reasons that in the opinion of the investigator does not justify the patients inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of ademetionine tablets on serum alanine aminotransferase (ALT) levels at Day 14 of treatment as compared to baseline in patients with alcoholic liver disease inclusive of fatty liver, alcoholic hepatitis, and alcoholic cirrhosis.Timepoint: Day 14 and 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 To evaluate the effectiveness of ademetionine tablets on serum ALT levels at Day 28 of treatment as compared to baseline in patients with alcoholic liver disease inclusive of fatty liver, alcoholic hepatitis, and alcoholic cirrhosis. 2 To evaluate the effectiveness of ademetionine tablets on serum aspartate aminotransferase (AST), GGT, serum alkaline phosphatase (ALP), serum total bilirubin (STB) and serum conjugated bilirubin (SCB) levels at Day 14 and 28 of treatment as compared to baseline in patients with alcoholic liver disease inclusive of fatty liver, alcoholic hepatitis, and alcoholic cirrhosis. 3. To evaluate the effectiveness of ademetionine tablets on serum AST and ALT ratio at Days 14 and 28 of treatment as compared to baseline in patients with alcoholic liver disease inclusive of fatty liver, alcoholic hepatitis, and alcoholic cirrhosis. 4.Timepoint: Day 14 and 28 | — |
Countries
India
Contacts
Public ContactDr Ashish Kumar
Sir Ganga Ram Hospital
Outcome results
None listed