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Tests treatment safety and results for Chronic Liver Disease
Official title 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
ClinicalTrials.gov ID: NCT06493799
What this study is testing
What is LAENNEC (Human Placenta Hydrolysate) IV?
LAENNEC (Human Placenta Hydrolysate) IV is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic liver disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Control group : LAENNEC subcutaneous injection (4 ml) Experimental group : LAENNEC intravenous injection (10 ml)
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 70
You may be able to join if
- A participant will be eligible for participation in the trial if all of the following 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.
You likely can't join if
- 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...
See the full eligibility criteria
- A participant will be eligible for participation in the trial if all of the following 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.
- 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...
- Those who judged that other testors were inappropriate as clinical trials
The study team makes the final eligibility decision.
Where it's taking place
- Yongin-si, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Yongin-si, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.