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Completed

NCT Number: NCT05532124

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.

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.

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Key information

Conditions

Chronic Liver Disease

Age range

19 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Keimyung university dongsan medical center, Daegu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

Treatment and study plan

LAENNEC (Human Placenta Hydrolysate)

Biological

Intravenous Injection

Normal Saline

Other

Intravenous Injection

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. PartA: Change amoust of ALT

    Time frame: week 2, 4 and 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.

  2. PartA: Adverse Event and clinical trials test

    Time frame: week 6

    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).

  3. PartB: Adverse Event and clinical trials test

    Time frame: week 6

    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).

  4. PartB: Major liver function test (ALT, AST, γ-GT, total bilirubin)

    Time frame: week 2, 4 and 6

    Change amoust of ALT, AST, γ-GT, total bilirubin.

    Independent Two Sample T-Test compares the difference between the group

Other outcomes

  1. PartA: Fat liver decrease effect (MRS)

    Time frame: week 6

    Absolute change from baseline in mean liver fat (MRS)

    Independent Two Sample T-Test compares the difference between the group

  2. PartB: Fat liver decrease effect (MRS)

    Time frame: week 6

    Absolute change from baseline in mean liver fat (MRS)

    Independent Two Sample T-Test compares the difference between the group

Sponsors and collaborators

Lead sponsor

Green Cross Wellbeing

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2022
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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