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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Change in ALT level relative to baseline at 6 weeks [Срок оценки: week 6]

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• GC wellbeing — Yongin-si

Идентификаторы

NCT: NCT06493799 · LAEN-IV3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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