Clinical trial NCT06493799: 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
Official title: A Multicenter, Randomized, Open-label, Active-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Drop of 'LAENNEC INJ. (Human Placenta Hydrolysate) Compared With Subcutaneous Injection in Patients With Chronic Liver Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Chronic Liver Disease
Lead sponsor: Green Cross Wellbeing
Sponsor class: INDUSTRY
First posted: 2024-07-10
Enrollment: 226
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

A participant will be eligible for participation in the trial if all of the following inclusion criteria are met:

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:

A participant will not be eligible for trial participation if any of the following exclusion criteria are met:

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

Primary outcomes:
measure: Change in ALT level relative to baseline at 6 weeks
timeFrame: week 6
Secondary outcomes:
measure: Change in ALT level relative to baseline at 2, 4 weeks
timeFrame: week 2, 4
measure: Change in AST, Total Bilirubin and r-GT level relative to baseline at 2, 4, 6 weeks
timeFrame: week 2, 4, 6
measure: The rate of ALT normalization at 2, 4, 6 weeks
timeFrame: week 2, 4, 6
measure: The rate of AST normalization at 2, 4, 6 weeks
timeFrame: week 2, 4, 6
measure: ALT normalization time
timeFrame: during 6 week
measure: The Rate of participants with ≤ 20% decrease of ALT relative to baseline at 2, 4 weeks
timeFrame: week 2, 4, 6
measure: Change in FSS score relative to baseline at 6 weeks
timeFrame: week 6
Other outcomes:
Locations:
Study officials:
affiliation: 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea
name: Seung Up Kim, Ph.D.
role: STUDY_DIRECTOR
affiliation: 222-1, Wangsimni-ro, Seongdong-gu, Seoul, Republic of Korea
name: Eileen Laurel Yoon, Ph.D.
role: STUDY_DIRECTOR
affiliation: 170, Jomaru-ro, Wonmi-gu, Bucheon-si, Gyeonggi-do, Republic of Korea
name: Sang Gyune Kim, Ph.D.
role: STUDY_DIRECTOR
affiliation: 323, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea
name: Yuri Cho, Ph.D.
role: STUDY_DIRECTOR
affiliation: 27, Inhang-ro, Jung-gu, Incheon, Republic of Korea
name: Jung Hwan Yu, Ph.D.
role: STUDY_DIRECTOR
affiliation: 29, Saemunan-ro, Jongno-gu, Seoul, Republic of Korea
name: Won Sohn, Ph.D.
role: STUDY_DIRECTOR
affiliation: 807, Hoguk-ro, Buk-gu, Daegu, Republic of Korea
name: Soo Young Park, Ph.D.
role: STUDY_DIRECTOR
affiliation: 1035, Dalgubeol-daero, Dalseo-gu, Daegu, Republic of Korea
name: Byoung Kuk Jang, Ph.D.
role: STUDY_DIRECTOR
affiliation: 59, Daesagwan-ro, Yongsan-gu, Seoul, Republic of Korea
name: Soung Won Jeong, Ph.D.
role: STUDY_DIRECTOR
affiliation: 102, Heukseok-ro, Dongjak-gu, Seoul, Republic of Korea
name: Young Youn Cho, Ph.D.
role: STUDY_DIRECTOR
affiliation: 101, Daehak-ro, Jongno-gu, Seoul, Republic of Korea
name: Eun Ju Cho, Ph.D.
role: STUDY_DIRECTOR
affiliation: 70, Hyeonchung-ro, Nam-gu, Daegu, Republic of Korea
name: Jung Gil Park, Ph.D.
role: STUDY_DIRECTOR
affiliation: 56, Dongsu-ro, Bupyeong-gu, Incheon, Republic of Korea
name: Jung Hyun Kwon, Ph.D.
role: STUDY_DIRECTOR
affiliation: 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic of Korea
name: Young Kul Jung, Ph.D.
role: STUDY_DIRECTOR
affiliation: 363, Dongbaekjukjeon-daero, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea
name: Ja Kyung Kim, Ph.D.
role: STUDY_DIRECTOR
affiliation: 211, Eonju-ro, Gangnam-gu, Seoul, Republic of Korea
name: Hyun Woong Lee, Ph.D.
role: STUDY_DIRECTOR
affiliation: 120-1, Neungdong-ro, Gwangjin-gu, Seoul, Republic of Korea
name: Won Hyeok Choe, Ph.D.
role: STUDY_DIRECTOR
affiliation: 100, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea
name: Chun Kyon Lee, Ph.D.
role: STUDY_DIRECTOR
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