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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Change in ALT level relative to baseline at 6 weeks
研究概览
简要总结
Control group : LAENNEC subcutaneous injection (4 ml)
Experimental group : LAENNEC intravenous injection (10 ml)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
LAENNEC 10 ml(Intravenous Injection)
Dosing twice a week for 6 weeks
干预措施: LAENNEC (Human Placenta Hydrolysate) IV (Drug)
LAENNEC 4 ml(Subcutaneous Injection)
Dosing twice a week for 6 weeks
干预措施: LAENNEC (Human Placenta Hydrolysate) SC (Drug)
结局指标
主要结局
Change in ALT level relative to baseline at 6 weeks
时间窗: week 6
In order to compare the test groups and control groups, check the ALT change after 6 weeks compared to the baseline. For the 6 week ALT change amount, a civic analysis (ANCOVA) is performed with the ALT level of the base line and the tamed dynasty (alcohol liver disease/non -alcohol liver liver disease) in a covenant. In addition, depending on the normal distribution of the data, the Paired t-test or Wilcoxon's rank test is performed to confirm the difference in the average change in the military.
次要结局
- Change in ALT level relative to baseline at 2, 4 weeks(week 2, 4)
- Change in AST, Total Bilirubin and r-GT level relative to baseline at 2, 4, 6 weeks(week 2, 4, 6)
- The rate of ALT normalization at 2, 4, 6 weeks(week 2, 4, 6)
- The rate of AST normalization at 2, 4, 6 weeks(week 2, 4, 6)
- ALT normalization time(during 6 week)
- The Rate of participants with ≤ 20% decrease of ALT relative to baseline at 2, 4 weeks(week 2, 4, 6)
- Change in FSS score relative to baseline at 6 weeks(week 6)