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

Launched by GREEN CROSS WELLBEING · Jul 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called LAENNEC, which is made from human placenta, to see how well it works and if it’s safe for patients with chronic liver diseases, such as alcoholic liver disease and non-alcoholic fatty liver disease. The trial will compare two ways of giving the treatment: one group will receive an intravenous (IV) injection directly into their bloodstream, while another group will receive a subcutaneous (under the skin) injection. The trial is not yet recruiting participants, but they are looking for adults between the ages of 19 and 70 who have been diagnosed with one of these liver diseases and have certain liver enzyme levels.

To be part of the trial, participants must fit specific criteria, such as having elevated ALT levels (a liver enzyme) and being able to sign consent forms. However, people with certain serious conditions, such as liver cancer, severe liver problems, or those who have had certain surgeries or are on specific medications, will not be eligible. Participants can expect to receive either the IV or subcutaneous treatment and will be monitored for safety and effectiveness throughout the study. This trial aims to find a new treatment option for those suffering from chronic liver diseases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• A participant will be eligible for participation in the trial if all of the following inclusion criteria are met:
• • 1. At the time of screening, 19 or 70 years
• • 2. Those who have been diagnosed with alcoholic or non-alcoholic fatty liver disease
• • 3. Those who have increased ALT level (Increased ALT level : 60 IU/L ≤ ALT ≤ 200 IU/L)
• • 4. A person who can complete the signature agreement and comply with clinical trial requirements.
• Exclusion Criteria:
• A participant will not be eligible for trial participation if any of the following exclusion criteria are met:
• • 1. 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)
• • 2. 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
• • 3. 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
• • 4. If you take more alcohol than the recommended amount (Man 40 g/day, Woman 20 g/day)
• • 5. Drug allergic symptoms (oscillation, heat, itching)
• • 6. Those who have received other clinical drugs within 4 weeks before selecting a test subject
• • 7. Those who cannot inject intravenous infusions (5% Dextrose Inj.)
• • 8. 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)
• • 9. Those who judged that other testors were inappropriate as clinical trials