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

Green Cross Wellbeing

Status and phase: Not yet enrolling; Phase 3

Conditions: Chronic Liver Disease

Treatments: Drug: LAENNEC (Human Placenta Hydrolysate) SC; Drug: LAENNEC (Human Placenta Hydrolysate) IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT06493799

LAEN-IV3

Details and patient eligibility

About

Control group : LAENNEC subcutaneous injection (4 ml)

Experimental group : LAENNEC intravenous injection (10 ml)

Full 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.

Enrollment: 226 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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226 participants in 2 patient groups

LAENNEC 10 ml(Intravenous Injection)

Experimental group

Description:

Dosing twice a week for 6 weeks

Treatment:

Drug: LAENNEC (Human Placenta Hydrolysate) IV

LAENNEC 4 ml(Subcutaneous Injection)

Active Comparator group

Description:

Dosing twice a week for 6 weeks

Treatment:

Drug: LAENNEC (Human Placenta Hydrolysate) SC