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Chronic Liver DiseasePhase 3NCT06493799

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 Phase 3 study testing LAENNEC (Human Placenta Hydrolysate) IV and LAENNEC (Human Placenta Hydrolysate) SC in people with Chronic Liver Disease, run by Green Cross Wellbeing at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Control group : LAENNEC subcutaneous injection (4 ml) Experimental group : LAENNEC intravenous injection (10 ml) Read more about this study

Who is it for?
Ages 19 to 70 years
Conditions the study is for
Chronic Liver Disease
What is being tested?
LAENNEC (Human Placenta Hydrolysate) IV and LAENNEC (Human Placenta Hydrolysate) SC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
1 siteSouth Korea
Study dates
1 Jul 2024to 30 Sep 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 33Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yeongmin Kwon contact

+82-70-8892-7881

ymkwon@gccorp.com

South Korea1 site, 1 recruiting

  • GC wellbeing

    Yongin-si

    Yeongmin Kwon, +82-70-8892-7881, ymkwon0116@gmail.com

    Recruiting

Other trials in South Korea

About this study

Official title: 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

Control group : LAENNEC subcutaneous injection (4 ml)

Experimental group : LAENNEC intravenous injection (10 ml)

Read the 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 efficacy of both 4 ml SC and 10ml IV LAENNEC when administered twice of week for 6 weeks. A total of 226 participants will be randomised to received 4ml SC or 10ml IV of LAENNEC a 1:1 ratio. And in 4 ml SC and 10 ml IV, the ratio of ALD and NAFLD is 1:3. The investigational product will be administered SC or IV twice of week for a duration of 6 weeks. Participants will return to the clinic for follow-up safety and efficacy assessments on weeks 2, 4, 6.

Being tested
LAENNEC (Human Placenta Hydrolysate) IV, LAENNEC (Human Placenta Hydrolysate) SC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LAENNEC (Human Placenta Hydrolysate) IVDrug

    Intravenous Injection

  • LAENNEC (Human Placenta Hydrolysate) SCDrug

    Subcutaneous Injection

Study groups in NCT06493799
Study groupRoleWhat they receive
LAENNEC 10 ml(Intravenous Injection)ExperimentalDosing twice a week for 6 weeks
Receives: Drug: LAENNEC (Human Placenta Hydrolysate) IV
LAENNEC 4 ml(Subcutaneous Injection)Active comparatorDosing twice a week for 6 weeks
Receives: Drug: LAENNEC (Human Placenta Hydrolysate) SC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in ALT level relative to baseline at 6 weeks

    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.

    Measured: week 6

Secondary outcomes (7)

  1. Change in ALT level relative to baseline at 2, 4 weeks

    In order to compare the test groups and control groups, check the ALT change after 2,4 weeks compared to the baseline.

    For the 2,4 weeks 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.

    Measured: week 2, 4

  2. Change in AST, Total Bilirubin and r-GT level relative to baseline at 2, 4, 6 weeks

    In order to compare the test groups and control groups, check the AST, Total Bilirubin and r-GT change after 2,4,6 weeks compared to the baseline.

    For the 2, 4, 6 weeks AST, Total Bilirubin and r-GT 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.

    Measured: week 2, 4, 6

  3. The rate of ALT normalization at 2, 4, 6 weeks

    Check the difference by conducting Chi-Square Test or Fisher's Exact Test for the number and ratio of the ALT normal level at 2, 4, 6 weeks.

    Measured: week 2, 4, 6

  4. The rate of AST normalization at 2, 4, 6 weeks

    Check the difference by conducting Chi-Square Test or Fisher's Exact Test for the number and ratio of the AST normal level at 2, 4, 6 weeks.

    Measured: week 2, 4, 6

  5. ALT normalization time

    It presents the time to normalize the ALT of the test group and the control group, and checks the difference between the test group and the control group using the log order test.

    Measured: during 6 week

  6. The Rate of participants with ≤ 20% decrease of ALT relative to baseline at 2, 4 weeks

    Check the difference by conducting Chi-Square Test or Fisher's Exact Test for the number and ratio of the ≤ 20% decrease of ALT relative to baseline at 2, 4, 6 weeks.

    Measured: week 2, 4, 6

  7. Change in FSS score relative to baseline at 6 weeks

    In order to compare the test groups and control groups, check the FSS change after 6 week compared to the baseline.

    For the 6 week FSS 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.

    Measured: week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2024
  2. Study start1 Jul 2024
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
226 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06493799
Sponsor's protocol ID
LAEN-IV3
Status last verified
Feb 2026
First submitted
30 Jun 2024
Last updated
25 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LAENNEC (Human Placenta Hydrolysate) IV and LAENNEC (Human Placenta Hydrolysate) SC in people with Chronic Liver Disease, run by Green Cross Wellbeing at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yeongmin Kwon (+82-70-8892-7881, ymkwon@gccorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in ALT level relative to baseline at 6 weeks (time frame: week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06493799.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

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