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

A Multicenter, Randomized, Open-label, Active-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Drop of 'LAENNEC INJ. (Human Placenta Hydrolysate) Compared With Subcutaneous Injection in Patients With Chronic Liver Disease

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) is a Phase 3 interventional studying Chronic Liver Disease, sponsored by Green Cross Wellbeing. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Control group : LAENNEC subcutaneous injection (4 ml) Experimental group : LAENNEC intravenous injection (10 ml)

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Chronic Liver Disease, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 226 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Chronic Liver Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

LAENNEC (Human Placenta Hydrolysate) IV

Intravenous Injection

DRUG

LAENNEC (Human Placenta Hydrolysate) SC

Subcutaneous Injection

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

GC wellbeing

Yongin-si, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06493799), the sponsor (Green Cross Wellbeing), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06493799 clinical trial studying?

Control group : LAENNEC subcutaneous injection (4 ml) Experimental group : LAENNEC intravenous injection (10 ml) The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06493799?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06493799?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06493799. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06493799. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.