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

Korábbi kezelés

• 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

Más betegség

• Drug allergic symptoms (oscillation, heat, itching)

Laborértékek

• 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)

Életkor

• 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)

Egyéb

• 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

• 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.