In Patients With Chronic Liver Diseases(Alcoholic Liver Disease and Non-Alcoholic Fatty Liver Disease), LAENNEC(Human Placenta Hydrolysate) is to Evaluate the Efficacy and Safety of Intravenous Drop

Ki vehet részt

• A participant will be eligible for participation in the trial if all of the following inclusion criteria are met:
• At the time of screening, 19 or 70 years
• Those who have been diagnosed with alcoholic or non-alcoholic fatty liver disease
• Those who have increased ALT level (Increased ALT level : 60 IU/L ≤ ALT ≤ 200 IU/L)
• A person who can complete the signature agreement and comply with clinical trial requirements

Ki nem vehet részt

• If you are taking the following drug (Hepatotonics); However, it is possible to register after having a drug holiday; Biphenyl dimethyl dicarboxylate (BDD), Silymarin(Milk thistle) : 14 days; Ursodeoxycholic acid (UDCA) : 30 days; Other Hepatotonics : 5 times half-life
• If you are taking the following drug or need to take drugs during the clinical trial period; Antituberculous drug(Isoniazid, Rifampin etc.), antifungal agent and antibiotic; Acetaminophen, NSAIDs(Excluding low-dose aspirin for preventive purposes); Lipid lowering agent(Niacin etc.) and Oral hypoglycemic agent(acarbose etc.) (Registered when administered during the clinical trial period with a certain dose without a change in dose currently being taken); Antiseric agent (ARB, Beta-blocker, CCB etc.) (Registered when administered during the clinical trial period with a certain dose without a change in dose currently being taken); Vitamin E (Purpose of treatment of more than 800 IU/day); Astrogens; Systemic corticosteroids, Immunomodulator
• Those who have received other clinical drugs within 4 weeks before selecting a test subject
• Drug allergic symptoms (oscillation, heat, itching)
• If you have the following disease; Liver cancer or other malignant tumor within 5 years at screening point; Esophageal varix bleeding, hepatic coma, ascites etc. related disease or Child-Pugh Score Class B,C patient within 1 year at screening point; Organs or bone marrow transplant experience; Billiary atresia, Genetic metabolic liver disease, Fulminant Hepatic failure, toxicity or Clinically diagnosed hepatitis, bleeding or Platelet disease patient; Autoimmune hepatitis, Primary biliary cirrhosis, Sclerosing cholangitis, IgG4- associated cholangitis patient; Bariatric Surgery within 24 weeks at screening point; Uncontrolled diabetes mellitus (HBA1c > 9.0%); Uncontrolled serious Cardiopulmonary disease; Liver cancer or other malignant tumor within 5 years at screening point; Those who have alcohol abuse within 5 years at screening point; Hepatitis B, C virus (However, those who have been identified as HBV DNA undetectable or SVR after antiviral administration can participate); Systemic infection (including tuberculosis)
• A person who does not perform appropriate contraception as a pregnant woman, a nursing or a woman of childbearing age (effective contraception method: Barrier methods using infertility surgery, uterine device, condom, killer)
• A participant will not be eligible for trial participation if any of the following exclusion criteria are met:
• If you take more alcohol than the recommended amount (Man 40 g/day, Woman 20 g/day)
• Those who cannot inject intravenous infusions (5% Dextrose Inj.)
• Those who judged that other testors were inappropriate as clinical trials