Actively Recruiting

Phase 3
Age: 19Years - 70Years
All Genders
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

Led by Green Cross Wellbeing · Updated on 2026-02-25

226

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 19 and 70 years at screening
  • Diagnosed with alcoholic or non-alcoholic fatty liver disease
  • ALT level between 60 IU/L and 200 IU/L
  • Able to sign consent and comply with study requirements
Not Eligible

You will not qualify if you...

  • History of liver cancer or other malignant tumors within 5 years
  • Liver-related conditions such as esophageal varix bleeding, hepatic coma, ascites, or Child-Pugh Score Class B or C within 1 year
  • Past organ or bone marrow transplant
  • Presence of biliary atresia, genetic metabolic liver disease, fulminant hepatic failure, toxicity, clinically diagnosed hepatitis, bleeding, or platelet disease
  • Autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, or IgG4-associated cholangitis
  • Bariatric surgery within 24 weeks
  • Uncontrolled diabetes with HbA1c over 9.0%
  • Uncontrolled serious cardiopulmonary disease
  • Alcohol abuse within 5 years
  • Hepatitis B or C virus infection unless HBV DNA is undetectable or sustained virologic response after antiviral therapy
  • Systemic infections including tuberculosis
  • Current use of hepatotonic drugs without appropriate drug holiday
  • Need to take antituberculous, antifungal, antibiotic drugs, acetaminophen, NSAIDs (except low-dose aspirin), lipid-lowering or oral hypoglycemic agents (unless stable dose), antiseric agents (unless stable dose), high-dose vitamin E, estrogens, systemic corticosteroids, or immunomodulators during the study
  • Consuming alcohol above recommended limits (men 40 g/day, women 20 g/day)
  • History of drug allergy symptoms such as rash, heat, or itching
  • Use of other clinical drugs within 4 weeks before enrollment
  • Unable to receive intravenous infusions (5% Dextrose Injection)
  • Pregnant, nursing, or women of childbearing potential not using effective contraception
  • Other conditions judged inappropriate for clinical trial participation by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

GC wellbeing

Yongin-si, South Korea

Actively Recruiting

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Research Team

Y

Yeongmin Kwon

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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