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.

NCT05532124 | Completed Phase 2

• 1 other identifier: LAEN-IV2A
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  week 6

Secondary Outcomes (4)

• PartA: Change amoust of ALT

  week 2, 4 and 6

• PartA: Adverse Event and clinical trials test

  week 6

• PartB: Adverse Event and clinical trials test

  week 6

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

  week 2, 4 and 6

Other Outcomes (2)

• PartA: Fat liver decrease effect (MRS)

  week 6

• PartB: Fat liver decrease effect (MRS)

  week 6

Study Arms (7)

Part A: LAENNEC 4ml

EXPERIMENTAL

Dosing twice a week for 2 weeks

Biological: LAENNEC (Human Placenta Hydrolysate)

Part A: LAENNEC 6ml

EXPERIMENTAL

Dosing twice a week for 2 weeks

Biological: LAENNEC (Human Placenta Hydrolysate)

Part A: LAENNEC 10ml

EXPERIMENTAL

Dosing twice a week for 2 weeks

Biological: LAENNEC (Human Placenta Hydrolysate)

Part A: Normal Saline

ACTIVE COMPARATOR

Dosing twice a week for 2 weeks

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.

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.

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.

Other: normal saline

Interventions

LAENNEC (Human Placenta Hydrolysate) BIOLOGICAL

Intravenous Injection

Part A: LAENNEC 10ml; Part A: LAENNEC 4ml; Part A: LAENNEC 6ml; Part B: LAENNEC 1; Part B: LAENNEC 2

normal saline OTHER

Intravenous Injection

Part A: Normal Saline; Part B: Normal Saline

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Green Cross Wellbeing: lead

Study Sites (7)

Keimyung university dongsan medical center

Daegu, South Korea

Location

Yeungnam university

Daegu, South Korea

Location

Hanyang University Hospital.

Seoul, South Korea

Location

Korea university guro hospital

Seoul, South Korea

Location

Severance hospital

Seoul, South Korea

Location

Soonchunhyang university hospital

Seoul, South Korea

Location

Wonju severance christian hospital

Wŏnju, South Korea

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 8, 2022
• Study Start: June 1, 2021
• Primary Completion: May 25, 2023
• Study Completion: September 27, 2023
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

KR (7)