Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Green Cross Wellbeing
Conditions:
Chronic Liver Disease
Eligibility:
All Genders
19-70 years
Phase:
PHASE3
Brief Summary
Control group : LAENNEC subcutaneous injection (4 ml) Experimental group : LAENNEC intravenous injection (10 ml)
Detailed Description
This is a multi- center, randomized, open-label, Active-controlled phase 3 trial in participants aged 18 to 70 years with chronic liver disease. It is designed to assess the safety, tolerability and e...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- A participant will not be eligible for trial participation if any of the following exclusion criteria are met:
- 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)
- 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
- If you take more alcohol than the recommended amount (Man 40 g/day, Woman 20 g/day)
- Drug allergic symptoms (oscillation, heat, itching)
- Those who have received other clinical drugs within 4 weeks before selecting a test subject
- Those who cannot inject intravenous infusions (5% Dextrose Inj.)
- 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)
- Those who judged that other testors were inappropriate as clinical trials
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT06493799
Start Date
July 1 2024
End Date
December 31 2025
Last Update
July 10 2024
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