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

NCT06493799 | Recruiting Phase 3

• 1 other identifier: LAEN-IV3
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

Control group : LAENNEC subcutaneous injection (4 ml) Experimental group : LAENNEC intravenous injection (10 ml)

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (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.

  week 6

Secondary Outcomes (7)

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

  week 2, 4

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

  week 2, 4, 6

• The rate of ALT normalization at 2, 4, 6 weeks

  week 2, 4, 6

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

  week 2, 4, 6

• ALT normalization time

  during 6 week

Study Arms (2)

LAENNEC 10 ml(Intravenous Injection)

EXPERIMENTAL

Dosing twice a week for 6 weeks

Drug: LAENNEC (Human Placenta Hydrolysate) IV

LAENNEC 4 ml(Subcutaneous Injection)

ACTIVE COMPARATOR

Dosing twice a week for 6 weeks

Drug: LAENNEC (Human Placenta Hydrolysate) SC

Interventions

LAENNEC (Human Placenta Hydrolysate) IV DRUG

Intravenous Injection

LAENNEC 10 ml(Intravenous Injection)

LAENNEC (Human Placenta Hydrolysate) SC DRUG

Subcutaneous Injection

LAENNEC 4 ml(Subcutaneous Injection)

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Green Cross Wellbeing: lead

Study Sites (1)

GC wellbeing

Yongin-si, South Korea

RECRUITING

Study Officials

• Seung Up Kim, Ph.D.

  50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea

  STUDY DIRECTOR

• Eileen Laurel Yoon, Ph.D.

  222-1, Wangsimni-ro, Seongdong-gu, Seoul, Republic of Korea

  STUDY DIRECTOR

• Sang Gyune Kim, Ph.D.

  170, Jomaru-ro, Wonmi-gu, Bucheon-si, Gyeonggi-do, Republic of Korea

  STUDY DIRECTOR

• Yuri Cho, Ph.D.

  323, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea

  STUDY DIRECTOR

• Jung Hwan Yu, Ph.D.

  27, Inhang-ro, Jung-gu, Incheon, Republic of Korea

  STUDY DIRECTOR

• Won Sohn, Ph.D.

  29, Saemunan-ro, Jongno-gu, Seoul, Republic of Korea

  STUDY DIRECTOR

• Soo Young Park, Ph.D.

  807, Hoguk-ro, Buk-gu, Daegu, Republic of Korea

  STUDY DIRECTOR

• Byoung Kuk Jang, Ph.D.

  1035, Dalgubeol-daero, Dalseo-gu, Daegu, Republic of Korea

  STUDY DIRECTOR

• Soung Won Jeong, Ph.D.

  59, Daesagwan-ro, Yongsan-gu, Seoul, Republic of Korea

  STUDY DIRECTOR

• Young Youn Cho, Ph.D.

  102, Heukseok-ro, Dongjak-gu, Seoul, Republic of Korea

  STUDY DIRECTOR

• Eun Ju Cho, Ph.D.

  101, Daehak-ro, Jongno-gu, Seoul, Republic of Korea

  STUDY DIRECTOR

• Jung Gil Park, Ph.D.

  70, Hyeonchung-ro, Nam-gu, Daegu, Republic of Korea

  STUDY DIRECTOR

• Jung Hyun Kwon, Ph.D.

  56, Dongsu-ro, Bupyeong-gu, Incheon, Republic of Korea

  STUDY DIRECTOR

• Young Kul Jung, Ph.D.

  123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic of Korea

  STUDY DIRECTOR

• Ja Kyung Kim, Ph.D.

  363, Dongbaekjukjeon-daero, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea

  STUDY DIRECTOR

• Hyun Woong Lee, Ph.D.

  211, Eonju-ro, Gangnam-gu, Seoul, Republic of Korea

  STUDY DIRECTOR

• Won Hyeok Choe, Ph.D.

  120-1, Neungdong-ro, Gwangjin-gu, Seoul, Republic of Korea

  STUDY DIRECTOR

• Chun Kyon Lee, Ph.D.

  100, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea

  STUDY DIRECTOR

Central Study Contacts

Yeongmin Kwon

CONTACT

+82-70-8892-7881; ymkwon@gccorp.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 10, 2024
• Study Start: July 1, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

KR (1)