Clinical Trials in South Korea / NCT06493799
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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