Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption

Exclusion Criteria

• •Subjects with a known hypersensitivity to the active substance of ademetionine or to any of the inactive ingredients
• •Subjects with extrahepatic cause of cholestasis (proven by ultrasound or described in medical history)
• •Diagnosis of human immunodeficiency virus (HIV) in medical history
• •Subjects with chronic liver disease Child-Pugh class C
• •Subjects in the decompensation stage of ALD (such as Maddrey Score \>32)
• •Subjects with primary sclerosing cholangitis (PSC)
• •Subjects with primary biliary cirrhosis (PBC)
• •Any form of malignancy within the past 5 years and/or basal cell carcinoma and squamous cell carcinoma of the skin within the past two years
• •Subjects with drug-induced liver disease
• •History of active substance abuse (oral, inhaled or injected) within one year prior to the study
• •Subjects with renal impairment (creatinine level of \>2.0 mg/dL or \> 150 µmol/l)
• •Subjects 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
• •Subjects on total parenteral nutrition in the year prior to screening
• •Subjects after or planned for bariatric surgery (jejunoileal bypass or gastric weight loss surgery)
• •Subjects after liver transplantation and subjects on the waiting list for liver transplantation
• •Subjects with any of the following disease in medical history:
• •Viral hepatitis (serum positive HBcAb or Hepatitis C Virus (HCV) RNA)
• •Evidence of autoimmune liver disease
• •Wilson´s disease
• •Hemochromatosis
• •Alpha-1-antitrypsin deficiency
• •Subjects with history of biliary diversion
• •History of major depression or bipolar disease
• •Women of childbearing potential: positive urine pregnancy test during screening or unwillingness to use an effective form of birth control during the study.
• •Breastfeeding women
• •Any condition that, in the opinion of the investigator, does not justify the patient's inclusion into the study
• •Investigational drug intake within one month prior to the study
• •Active, serious medical disease other than ALD with likely life-expectancy less than five years