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

Overview

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.

Interventions

• Drug LAENNEC (Human Placenta Hydrolysate) IV
  Intravenous Injection
• Drug LAENNEC (Human Placenta Hydrolysate) SC
  Subcutaneous Injection

Primary outcome measures

• Change in ALT level relative to baseline at 6 weeks [Time frame: week 6]

Secondary outcome measures (7)

• Change in ALT level relative to baseline at 2, 4 weeks [Time frame: week 2, 4]
• Change in AST, Total Bilirubin and r-GT level relative to baseline at 2, 4, 6 weeks [Time frame: week 2, 4, 6]
• The rate of ALT normalization at 2, 4, 6 weeks [Time frame: week 2, 4, 6]
• The rate of AST normalization at 2, 4, 6 weeks [Time frame: week 2, 4, 6]
• ALT normalization time [Time frame: during 6 week]
• The Rate of participants with ≤ 20% decrease of ALT relative to baseline at 2, 4 weeks [Time frame: week 2, 4, 6]
• Change in FSS score relative to baseline at 6 weeks [Time frame: week 6]

Eligibility criteria

Inclusion criteria

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

• 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 criteria

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

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

South Korea · 1 center

• GC wellbeing — Yongin-si

Identifiers

NCT: NCT06493799 · LAEN-IV3

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗