Ireland
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Recruiting Phase 3

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

NCT06493799 · tracked via the Priya Life Science South Korea tracker
Sponsor
Green Cross Wellbeing
Phase
Phase 3
Started
2024-07-01
Last updated
2026-02-25

Condition(s) studied

Chronic Liver Disease

Investigational drug(s) / intervention(s)

LAENNEC (Human Placenta Hydrolysate) IVLAENNEC (Human Placenta Hydrolysate) SC

LAENNEC (Human Placenta Hydrolysate) IV: Intravenous Injection

LAENNEC (Human Placenta Hydrolysate) SC: Subcutaneous Injection

Study summary

Control group : LAENNEC subcutaneous injection (4 ml)

Experimental group : LAENNEC intravenous injection (10 ml)

Eligibility

Sex
ALL
Min age
19 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in ALT level relative to baseline at 6 weeks — week 6
    In order to compare the test groups and control groups, check the ALT change after 6 weeks compared to the baseline. For the 6 week ALT change amount, a civic analysis (ANCOVA) is performed with the ALT level of the base line and the tamed dynasty (alcohol liver disease/non -alcohol liver liver disease) in a covenant. In addition, depending on the normal distribution of the data, the Paired t-test or Wilcoxon's rank test is performed to confirm the difference in the average change in the military.

Trial sites (1)

FacilityCityRegionStatus
GC wellbeing Yongin-si South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06493799 on ClinicalTrials.gov ↗ ← All trials in South Korea