LAENNEC (Human Placenta Hydrolysate) Stiffness of Chronic Liver Disease Patients to Evaluate the Safety and Effectiveness of Multi -Tube, Eye, Placebo, and Capacity Increase and Capacity Enlargement Clinical Trial to Assess the Safety and Effectiveness
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 7
- 主要终点
- PartA: Adverse Event and clinical trials test
研究概览
简要总结
Part A: In Patients With Chronic Liver Diseases, LAENNEC (Human Placenta Hydrolysate) is to Assess Safety and Tolerability After the Doses of Doses.
Part B: Part A, it is to Determine the Optimal Dose by Evaluating Two Capacity and Placebo Groups.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At the time of screening, 18 or 75 years
- •Those who have been diagnosed with alcoholic or non -alcoholic fatty liver disease and have persisted for more than 6 months
- •Those who are 1.5 times (60 IU/L) of the ALT level of Baseline (60 IU/L)
- •A person who can complete the signature agreement and compliance the requirements for clinical trials.
排除标准
- •Liver function abnormalities caused by the following cause disease: viral hepatitis, biliary obstructions, autoimmune hepatitis, wilson disease, hematoprive
- •Drug allergic symptoms (oscillation, heat, itching)
- •Those with systemic infection (including tuberculosis)
- •If the test person judges that it is difficult to participate in clinical trials due to the next disease: Cirrhosis of CHILD C or higher, cirrhosis with edema and plural, malignant tumors, severe disorders, severe renal disorders, severe cardiovascular disease, severe nerve Mental disorders, preferences, etc.
- •Those who have experienced use of human -derived medicines within 6 months before selecting a test subject
- •Those who have received other clinical drugs within 3 months before selecting a test subject
- •Magnetic Resonance Spectroscopy (MRS) is impossible
- •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 cannot inject intravenous infusions
- •Those who judged that other testors were inappropriate as clinical trials
研究组 & 干预措施
Part A: LAENNEC 4ml
Dosing twice a week for 2 weeks
干预措施: LAENNEC (Human Placenta Hydrolysate) (Biological)
Part A: LAENNEC 6ml
Dosing twice a week for 2 weeks
干预措施: LAENNEC (Human Placenta Hydrolysate) (Biological)
Part A: LAENNEC 10ml
Dosing twice a week for 2 weeks
干预措施: LAENNEC (Human Placenta Hydrolysate) (Biological)
Part A: Normal Saline
Dosing twice a week for 2 weeks
干预措施: normal saline (Other)
Part B: LAENNEC 1
It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.
干预措施: LAENNEC (Human Placenta Hydrolysate) (Biological)
Part B: LAENNEC 2
It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.
干预措施: LAENNEC (Human Placenta Hydrolysate) (Biological)
Part B: Normal Saline
It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.
干预措施: normal saline (Other)
结局指标
主要结局
PartA: Adverse Event and clinical trials test
时间窗: week 2
The ratio of the test subjects who have experienced more than one Adverse Event is compared with the Chi-Square Test or Fisher's Exact Test. For clinical trial tests, the amount of change in the group is paired T-test, and the amount of changes between the groups is conducted with Independent Two Sample T-Test. Mcnemar 's Test is performed for normal and abnormal changes in the administration of clinical trial tests, and the difference between the divisions between the group is performed with the Generalized Estimating Equation (GEE).
PartB: Change amoust of ALT
时间窗: week 6
The ALT improvement rate of the test group and the control group is presented. The ALT proposes a ratio of test subjects that decreased by more than 20% compared to the base value, and compares the difference between the group using the Chi-Square Test or Fisher's Exact Test.
次要结局
- PartB: Adverse Event and clinical trials test(week 6)
- PartA: Change amoust of ALT(week 2, 4 and 6)
- PartA: Adverse Event and clinical trials test(week 6)
- PartB: Major liver function test (ALT, AST, γ-GT, total bilirubin)(week 2, 4 and 6)