RecruitingPhase 3NCT06493799

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

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


Sponsor

Green Cross Wellbeing

Enrollment

226 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 19 YearsMax Age: 70 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria32

  • 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
  • Biphenyl dimethyl dicarboxylate (BDD), Silymarin(Milk thistle) : 14 days
  • Ursodeoxycholic acid (UDCA) : 30 days
  • Other Hepatotonics : 5 times half-life
  • 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
  • If you take more alcohol than the recommended amount (Man 40 g/day, Woman 20 g/day)
  • Drug allergic symptoms (oscillation, heat, itching)
  • Those who have received other clinical drugs within 4 weeks before selecting a test subject
  • Those who cannot inject intravenous infusions (5% Dextrose Inj.)
  • 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 judged that other testors were inappropriate as clinical trials

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Interventions

DRUGLAENNEC (Human Placenta Hydrolysate) IV

Intravenous Injection

DRUGLAENNEC (Human Placenta Hydrolysate) SC

Subcutaneous Injection


Locations(1)

GC wellbeing

Yongin-si, South Korea

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NCT06493799


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