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

NCT ID: NCT06493799

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-12-31

Brief Summary

Control group : LAENNEC subcutaneous injection (4 ml)

Experimental group : LAENNEC intravenous injection (10 ml)

Detailed Description

This is a multi- center, randomized, open-label, Active-controlled phase 3 trial in participants aged 18 to 70 years with chronic liver disease. It is designed to assess the safety, tolerability and efficacy of both 4 ml SC and 10ml IV LAENNEC when administered twice of week for 6 weeks. A total of 226 participants will be randomised to received 4ml SC or 10ml IV of LAENNEC a 1:1 ratio. And in 4 ml SC and 10 ml IV, the ratio of ALD and NAFLD is 1:3. The investigational product will be administered SC or IV twice of week for a duration of 6 weeks. Participants will return to the clinic for follow-up safety and efficacy assessments on weeks 2, 4, 6.

Conditions

Chronic Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LAENNEC 10 ml(Intravenous Injection)

Dosing twice a week for 6 weeks

Group Type: EXPERIMENTAL

LAENNEC (Human Placenta Hydrolysate) IV

Intervention Type: DRUG

Intravenous Injection

LAENNEC 4 ml(Subcutaneous Injection)

Dosing twice a week for 6 weeks

Group Type: ACTIVE_COMPARATOR

LAENNEC (Human Placenta Hydrolysate) SC

Intervention Type: DRUG

Subcutaneous Injection

Interventions

LAENNEC (Human Placenta Hydrolysate) IV

Intravenous Injection

Intervention Type: DRUG

LAENNEC (Human Placenta Hydrolysate) SC

Subcutaneous Injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. At the time of screening, 19 or 70 years

2. Those who have been diagnosed with alcoholic or non-alcoholic fatty liver disease

3. Those who have increased ALT level (Increased ALT level : 60 IU/L ≤ ALT ≤ 200 IU/L)

4. A person who can complete the signature agreement and comply with clinical trial requirements.

Exclusion Criteria

1. 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)

2. If you are taking the following drug (Hepatotonics)

• However, it is possible to register after having a drug holiday

• Biphenyl dimethyl dicarboxylate (BDD), Silymarin(Milk thistle) : 14 days
• Ursodeoxycholic acid (UDCA) : 30 days
• Other Hepatotonics : 5 times half-life

3. If you are taking the following drug or need to take drugs during the clinical trial period

• Antituberculous drug(Isoniazid, Rifampin etc.), antifungal agent and antibiotic
• Acetaminophen, NSAIDs(Excluding low-dose aspirin for preventive purposes)
• Lipid lowering agent(Niacin etc.) and Oral hypoglycemic agent(acarbose etc.) (Registered when administered during the clinical trial period with a certain dose without a change in dose currently being taken)
• Antiseric agent (ARB, Beta-blocker, CCB etc.) (Registered when administered during the clinical trial period with a certain dose without a change in dose currently being taken)
• Vitamin E (Purpose of treatment of more than 800 IU/day)
• Astrogens
• Systemic corticosteroids, Immunomodulator

4. If you take more alcohol than the recommended amount (Man 40 g/day, Woman 20 g/day)

5. Drug allergic symptoms (oscillation, heat, itching)

6. Those who have received other clinical drugs within 4 weeks before selecting a test subject

7. Those who cannot inject intravenous infusions (5% Dextrose Inj.)

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 judged that other testors were inappropriate as clinical trials

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Green Cross Wellbeing

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seung Up Kim, Ph.D.

Role: STUDY_DIRECTOR

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

Eileen Laurel Yoon, Ph.D.

Role: STUDY_DIRECTOR

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

Sang Gyune Kim, Ph.D.

Role: STUDY_DIRECTOR

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

Yuri Cho, Ph.D.

Role: STUDY_DIRECTOR

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

Jung Hwan Yu, Ph.D.

Role: STUDY_DIRECTOR

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

Won Sohn, Ph.D.

Role: STUDY_DIRECTOR

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

Soo Young Park, Ph.D.

Role: STUDY_DIRECTOR

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

Byoung Kuk Jang, Ph.D.

Role: STUDY_DIRECTOR

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

Soung Won Jeong, Ph.D.

Role: STUDY_DIRECTOR

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

Young Youn Cho, Ph.D.

Role: STUDY_DIRECTOR

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

Eun Ju Cho, Ph.D.

Role: STUDY_DIRECTOR

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

Jung Gil Park, Ph.D.

Role: STUDY_DIRECTOR

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

Jung Hyun Kwon, Ph.D.

Role: STUDY_DIRECTOR

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

Young Kul Jung, Ph.D.

Role: STUDY_DIRECTOR

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

Ja Kyung Kim, Ph.D.

Role: STUDY_DIRECTOR

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

Hyun Woong Lee, Ph.D.

Role: STUDY_DIRECTOR

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

Won Hyeok Choe, Ph.D.

Role: STUDY_DIRECTOR

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

Chun Kyon Lee, Ph.D.

Role: STUDY_DIRECTOR

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

Central Contacts

Yeongmin Kwon

Role: CONTACT

ymkwon@gccorp.com

+82-70-8892-7881

Other Identifiers

LAEN-IV3

Identifier Type: -

Identifier Source: org_study_id