Chronic Liver DiseasePhase 2NCT05532124
Part A: In Patients With Chronic Liver Diseases, LAENNEC (Human Placenta Hydrolysate) is to Assess Safety and Tolerability After the Doses of Doses. Part B: Part A, it is to Determine the Optimal Dose by Evaluating Two Capacity and Placebo Groups.
A Phase 2 study testing LAENNEC (Human Placenta Hydrolysate) and normal saline in people with Chronic Liver Disease, run by Green Cross Wellbeing at 7 sites in South Korea.
Trial summary
Part A: In Patients With Chronic Liver Diseases, LAENNEC (Human Placenta Hydrolysate) is to Assess Safety and Tolerability After the Doses of Doses. Part B: Part A, it is to Determine the Optimal Dose by Evaluating Two Capacity and Placebo Groups. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- LAENNEC (Human Placenta Hydrolysate) and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 1 Jun 2021to 27 Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At the time of screening, 18 or 75 years
- Those who have been diagnosed with alcoholic or non -alcoholic fatty liver disease and have persisted for more than 6 months
- Those who are 1.5 times (60 IU/L) of the ALT level of Baseline (60 IU/L)
- A person who can complete the signature agreement and compliance the requirements for clinical trials.
Who cannot join
- Liver function abnormalities caused by the following cause disease: viral hepatitis, biliary obstructions, autoimmune hepatitis, wilson disease, hematoprive
- Drug allergic symptoms (oscillation, heat, itching)
- Those with systemic infection (including tuberculosis)
- If the test person judges that it is difficult to participate in clinical trials due to the next disease: Cirrhosis of CHILD C or higher, cirrhosis with edema and plural, malignant tumors, severe disorders, severe renal disorders, severe cardiovascular disease, severe nerve Mental disorders, preferences, etc.
- Those who have experienced use of human -derived medicines within 6 months before selecting a test subject
- Those who have received other clinical drugs within 3 months before selecting a test subject
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- Magnetic Resonance Spectroscopy (MRS) is impossible
- 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 cannot inject intravenous infusions
- Those who judged that other testors were inappropriate as clinical trials
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Keimyung university dongsan medical center
Daegu
Yeungnam university
Daegu
Hanyang University Hospital.
Seoul
Korea university guro hospital
Seoul
Severance hospital
Seoul
Soonchunhyang university hospital
Seoul
Wonju severance christian hospital
Wŏnju
About this study
Official title: LAENNEC (Human Placenta Hydrolysate) Stiffness of Chronic Liver Disease Patients to Evaluate the Safety and Effectiveness of Multi -Tube, Eye, Placebo, and Capacity Increase and Capacity Enlargement Clinical Trial to Assess the Safety and Effectiveness
Part A: In Patients With Chronic Liver Diseases, LAENNEC (Human Placenta Hydrolysate) is to Assess Safety and Tolerability After the Doses of Doses.
Part B: Part A, it is to Determine the Optimal Dose by Evaluating Two Capacity and Placebo Groups.
- Conditions
- Chronic Liver Disease
- Being tested
- LAENNEC (Human Placenta Hydrolysate), normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAENNEC (Human Placenta Hydrolysate)Biological
Intravenous Injection
normal salineOther
Intravenous Injection
| Study group | Role | What they receive |
|---|---|---|
| Part A: LAENNEC 4ml | Experimental | Dosing twice a week for 2 weeks Receives: Biological: LAENNEC (Human Placenta Hydrolysate) |
| Part A: LAENNEC 6ml | Experimental | Dosing twice a week for 2 weeks Receives: Biological: LAENNEC (Human Placenta Hydrolysate) |
| Part A: LAENNEC 10ml | Experimental | Dosing twice a week for 2 weeks Receives: Biological: LAENNEC (Human Placenta Hydrolysate) |
| Part A: Normal Saline | Active comparator | Dosing twice a week for 2 weeks Receives: Other: normal saline |
| Part B: LAENNEC 1 | Experimental | It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT. Receives: Biological: LAENNEC (Human Placenta Hydrolysate) |
| Part B: LAENNEC 2 | Experimental | It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT. Receives: Biological: LAENNEC (Human Placenta Hydrolysate) |
| Part B: Normal Saline | Active comparator | It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT. Receives: Other: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
PartA: Adverse Event and clinical trials test
The ratio of the test subjects who have experienced more than one Adverse Event is compared with the Chi-Square Test or Fisher's Exact Test.
For clinical trial tests, the amount of change in the group is paired T-test, and the amount of changes between the groups is conducted with Independent Two Sample T-Test.
Mcnemar 's Test is performed for normal and abnormal changes in the administration of clinical trial tests, and the difference between the divisions between the group is performed with the Generalized Estimating Equation (GEE).
Measured: week 2
PartB: Change amoust of ALT
The ALT improvement rate of the test group and the control group is presented. The ALT proposes a ratio of test subjects that decreased by more than 20% compared to the base value, and compares the difference between the group using the Chi-Square Test or Fisher's Exact Test.
Measured: week 6
Secondary outcomes (4)
PartA: Change amoust of ALT
The ALT improvement rate of the test group and the control group is presented. The ALT proposes a ratio of test subjects that decreased by more than 20% compared to the base value, and compares the difference between the group using the Chi-Square Test or Fisher's Exact Test.
Measured: week 2, 4 and 6
PartA: Adverse Event and clinical trials test
The ratio of the test subjects who have experienced more than one Adverse Event is compared with the Chi-Square Test or Fisher's Exact Test.
For clinical trial tests, the amount of change in the group is paired T-test, and the amount of changes between the groups is conducted with Independent Two Sample T-Test.
Mcnemar 's Test is performed for normal and abnormal changes in the administration of clinical trial tests, and the difference between the divisions between the group is performed with the Generalized Estimating Equation (GEE).
Measured: week 6
PartB: Adverse Event and clinical trials test
The ratio of the test subjects who have experienced more than one Adverse Event is compared with the Chi-Square Test or Fisher's Exact Test.
For clinical trial tests, the amount of change in the group is paired T-test, and the amount of changes between the groups is conducted with Independent Two Sample T-Test.
Mcnemar 's Test is performed for normal and abnormal changes in the administration of clinical trial tests, and the difference between the divisions between the group is performed with the Generalized Estimating Equation (GEE).
Measured: week 6
PartB: Major liver function test (ALT, AST, γ-GT, total bilirubin)
Change amoust of ALT, AST, γ-GT, total bilirubin.
Independent Two Sample T-Test compares the difference between the group
Measured: week 2, 4 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start1 Jun 2021
- Primary completion25 May 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Wellbeing
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532124
- Sponsor's protocol ID
- LAEN-IV2A
- Status last verified
- Feb 2026
- First submitted
- 1 Sep 2022
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LAENNEC (Human Placenta Hydrolysate) Stiffness of Chronic Liver Disease Patients to Evaluate the Safety and Effectiveness of Multi -Tube, Eye, Placebo, and Capacity Increase and Capacity Enlargement Clinical Trial to Assess the Safety and Effectiveness
- ClinicalTrials.gov ID
- NCT05532124
- Acronym / sponsor ID
- LAEN-IV2A
- Conditions
- Chronic Liver Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Green Cross WellbeingIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Part A: In Patients With Chronic Liver Diseases, LAENNEC (Human Placenta Hydrolysate) is to Assess Safety and Tolerability After the Doses of Doses.
Part B: Part A, it is to Determine the Optimal Dose by Evaluating Two Capacity and Placebo Groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A: LAENNEC 4ml | Experimental | Biological: LAENNEC (Human Placenta Hydrolysate)Dosing twice a week for 2 weeks |
| Part A: LAENNEC 6ml | Experimental | Biological: LAENNEC (Human Placenta Hydrolysate)Dosing twice a week for 2 weeks |
| Part A: LAENNEC 10ml | Experimental | Biological: LAENNEC (Human Placenta Hydrolysate)Dosing twice a week for 2 weeks |
| Part A: Normal Saline | Active comparator | Other: normal salineDosing twice a week for 2 weeks |
| Part B: LAENNEC 1 | Experimental | Biological: LAENNEC (Human Placenta Hydrolysate)It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT. |
| Part B: LAENNEC 2 | Experimental | Biological: LAENNEC (Human Placenta Hydrolysate)It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT. |
| Part B: Normal Saline | Active comparator | Other: normal salineIt is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT. |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At the time of screening, 18 or 75 years
- Those who have been diagnosed with alcoholic or non -alcoholic fatty liver disease and have persisted for more than 6 months
- Those who are 1.5 times (60 IU/L) of the ALT level of Baseline (60 IU/L)
- A person who can complete the signature agreement and compliance the requirements for clinical trials.
Key exclusion criteria (10 listed)
- Liver function abnormalities caused by the following cause disease: viral hepatitis, biliary obstructions, autoimmune hepatitis, wilson disease, hematoprive
- Drug allergic symptoms (oscillation, heat, itching)
- Those with systemic infection (including tuberculosis)
- If the test person judges that it is difficult to participate in clinical trials due to the next disease: Cirrhosis of CHILD C or higher, cirrhosis with edema and plural, malignant tumors, severe disorders, severe renal disorders, severe cardiovascular disease, severe nerve Mental disorders, preferences, etc.
- Those who have experienced use of human -derived medicines within 6 months before selecting a test subject
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAENNEC (Human Placenta Hydrolysate)Intravenous Injection | Biological | Part A: LAENNEC 10ml, Part A: LAENNEC 4ml, Part A: LAENNEC 6ml, Part B: LAENNEC 1, Part B: LAENNEC 2 |
| normal salineIntravenous Injection | Other | Part A: Normal Saline, Part B: Normal Saline |
Primary outcome
PartA: Adverse Event and clinical trials test
Time frame: week 2
The ratio of the test subjects who have experienced more than one Adverse Event is compared with the Chi-Square Test or Fisher's Exact Test. For clinical trial tests, the amount of change in the group is paired T-test, and the amount of changes between the groups is conducted with Independent Two Sample T-Test. Mcnemar 's Test is performed for normal and abnormal changes in the administration of clinical trial tests, and the difference between the divisions between the group is performed with the Generalized Estimating Equation (GEE).
PartB: Change amoust of ALT
Time frame: week 6
The ALT improvement rate of the test group and the control group is presented. The ALT proposes a ratio of test subjects that decreased by more than 20% compared to the base value, and compares the difference between the group using the Chi-Square Test or Fisher's Exact Test.
4 secondary outcomes
PartA: Change amoust of ALT
Time frame: week 2, 4 and 6
PartA: Adverse Event and clinical trials test
Time frame: week 6
PartB: Adverse Event and clinical trials test
Time frame: week 6
PartB: Major liver function test (ALT, AST, γ-GT, total bilirubin)
Time frame: week 2, 4 and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LAENNEC (Human Placenta Hydrolysate) and normal saline in people with Chronic Liver Disease, run by Green Cross Wellbeing at 7 sites 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 23 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 7 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PartA: Adverse Event and clinical trials test (time frame: week 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2026.