Actively Recruiting
A Multicenter, Randomized, Open-label, Active-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Drop Compared to Subcutaneous Injection of LAENNEC (Human Placenta Hydrolysate) in Patients With Chronic Liver Disease
Led by Green Cross Wellbeing · Updated on 2026-02-25
226
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients aged 18 to 70 years with chronic liver disease, including alcoholic liver disease and non-alcoholic fatty liver disease. This phase 3, multi-center, randomized, open-label trial compares the safety, tolerability, and effectiveness of LAENNEC (Human Placenta Hydrolysate) given as intravenous (IV) or subcutaneous (SC) injections. The goal is to evaluate how these two methods affect liver health, particularly by measuring changes in liver enzymes such as ALT. Participants are randomly assigned to receive either 10 ml of LAENNEC by intravenous injection or 4 ml by subcutaneous injection. Both groups will receive their assigned treatment twice a week for six weeks. The ratio of patients with alcoholic liver disease to those with non-alcoholic fatty liver disease is maintained at 1:3 in both treatment groups. Follow-up visits occur at weeks 2, 4, and 6 to monitor safety and effectiveness. During the study, participants will undergo laboratory tests to measure liver enzyme levels including ALT, AST, total bilirubin, and r-GT at various points. The primary outcome is the change in ALT level at week 6 compared to baseline. Secondary outcomes include changes in other liver enzymes and fatigue severity scores. Participants' adherence and safety are closely monitored throughout the trial, which lasts for six weeks of treatment plus follow-up assessments.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Age between 19 and 70 years at screening
- Diagnosed with alcoholic liver disease or non-alcoholic fatty liver disease
- Elevated ALT level between 60 IU/L and 200 IU/L
- Able to provide signed agreement and comply with trial requirements
You will not qualify if you...
- History of liver cancer or other malignant tumors within 5 years
- Esophageal varix bleeding, hepatic coma, ascites, or related diseases, or Child-Pugh Class B or C within 1 year
- Experience of organ or bone marrow transplant
- Diagnosed with biliary atresia, genetic metabolic liver disease, fulminant hepatic failure, 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 mellitus with HbA1c over 9.0%
- Uncontrolled serious cardiopulmonary disease
- Alcohol abuse within the past 5 years
- Hepatitis B or C virus infection unless HBV DNA undetectable or sustained virologic response after antiviral treatment
- Systemic infection including tuberculosis
- Taking hepatotonic drugs without required drug holiday
- Taking antituberculous drugs, antifungal agents, antibiotics, acetaminophen, NSAIDs (except low-dose aspirin), lipid-lowering agents, oral hypoglycemic agents, antihypertensives, high-dose vitamin E, estrogens, systemic corticosteroids, or immunomodulators as specified
- Consuming more alcohol than recommended limits (men over 40 g/day, women over 20 g/day)
- History of drug allergic symptoms such as itching or heat
- Use of other clinical drugs within 4 weeks before selection
- Unable to receive intravenous infusions
- Not using effective contraception if pregnant, nursing, or of childbearing potential
- Judged inappropriate for trial participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive LAENNEC by either intravenous injection or subcutaneous injection twice a week for 6 weeks to evaluate safety and efficacy.
Twice weekly visits for 6 weeks
Duration - Up to 6 weeks
Participants return to the clinic for follow-up safety and efficacy assessments after treatment.
Visits at weeks 2, 4, and 6
Trial Site Locations
Total: 1 location
1
GC wellbeing
Yongin-si, South Korea
Actively Recruiting
Research Team
Y
Yeongmin Kwon
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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