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.

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Liver Disease
• Intervention / Treatment: Biological: LAENNEC (Human Placenta Hydrolysate); Other: normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 49
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Recruiting
    • Keimyung University Dongsan Medical Center
    • Contact: Jae Seok Hwang, Ph.D.
  • Daegu, Korea, Republic of
    • Recruiting
    • Yeungnam University
    • Contact: Jung Gil Park, Ph. D
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Severance Hospital
    • Contact: Seung Up Kim, Ph D
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Soonchunhyang University Hospital
    • Contact: Jae Young Jang, Ph D
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Korea University Guro Hospital
    • Contact: Ji hoon Kim, Ph D
  • Seoul, Korea, Republic of
    • Recruiting
    • Hanyang University Hospital.
    • Contact: Dae Won Jun, Ph D
  • Wŏnju, Korea, Republic of
    • Recruiting
    • Wonju Severance Christian Hospital
    • Contact: Moon Young Kim, Ph D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. At the time of screening, 18 or 75 years
2. Those who have been diagnosed with alcoholic or non -alcoholic fatty liver disease and have persisted for more than 6 months
3. Those who are 1.5 times (60 IU/L) of the ALT level of Baseline (60 IU/L)
4. A person who can complete the signature agreement and compliance the requirements for clinical trials.

Exclusion Criteria:

1. Liver function abnormalities caused by the following cause disease: viral hepatitis, biliary obstructions, autoimmune hepatitis, wilson disease, hematoprive
2. Drug allergic symptoms (oscillation, heat, itching)
3. Those with systemic infection (including tuberculosis)
4. 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.
5. Those who have experienced use of human -derived medicines within 6 months before selecting a test subject
6. Those who have received other clinical drugs within 3 months before selecting a test subject
7. Magnetic Resonance Spectroscopy (MRS) is impossible
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 cannot inject intravenous infusions
10. Those who judged that other testors were inappropriate as clinical trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: LAENNEC 4ml; Dosing twice a week for 2 weeks	Biological: LAENNEC (Human Placenta Hydrolysate); Intravenous Injection
Experimental: Part A: LAENNEC 6ml; Dosing twice a week for 2 weeks	Biological: LAENNEC (Human Placenta Hydrolysate); Intravenous Injection
Experimental: Part A: LAENNEC 10ml; Dosing twice a week for 2 weeks	Biological: LAENNEC (Human Placenta Hydrolysate); Intravenous Injection
Active Comparator: Part A: Normal Saline; Dosing twice a week for 2 weeks	Other: normal saline; Intravenous Injection
Experimental: Part B: LAENNEC 1; 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); Intravenous Injection
Experimental: Part B: LAENNEC 2; 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); Intravenous Injection
Active Comparator: Part B: Normal Saline; It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.	Other: normal saline; Intravenous Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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	week 2, 4 and 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PartA: Fat liver decrease effect (MRS)	Absolute change from baseline in mean liver fat (MRS) Independent Two Sample T-Test compares the difference between the group	week 6
PartB: Fat liver decrease effect (MRS)	Absolute change from baseline in mean liver fat (MRS) Independent Two Sample T-Test compares the difference between the group	week 6

Collaborators and Investigators

• Sponsor: Green Cross Wellbeing

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 4, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 4, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: LAEN-IV2A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No