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
NCT Number: NCT06493799
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Chronic Liver Disease
Interventions: DRUG: LAENNEC (Human Placenta Hydrolysate) IV|DRUG: LAENNEC (Human Placenta Hydrolysate) SC
Sponsor: Green Cross Wellbeing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 226
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-12-31

Summary:
Control group : LAENNEC subcutaneous injection (4 ml)

Experimental group : LAENNEC intravenous injection (10 ml)

Primary Outcome Measures: Change in ALT level relative to baseline at 6 weeks, 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., week 6
Secondary Outcome Measures: Change in ALT level relative to baseline at 2, 4 weeks, In order to compare the test groups and control groups, check the ALT change after 2,4 weeks compared to the baseline.

For the 2,4 weeks 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., week 2, 4|Change in AST, Total Bilirubin and r-GT level relative to baseline at 2, 4, 6 weeks, In order to compare the test groups and control groups, check the AST, Total Bilirubin and r-GT change after 2,4,6 weeks compared to the baseline.

For the 2, 4, 6 weeks AST, Total Bilirubin and r-GT 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., week 2, 4, 6|The rate of ALT normalization at 2, 4, 6 weeks, Check the difference by conducting Chi-Square Test or Fisher's Exact Test for the number and ratio of the ALT normal level at 2, 4, 6 weeks., week 2, 4, 6|The rate of AST normalization at 2, 4, 6 weeks, Check the difference by conducting Chi-Square Test or Fisher's Exact Test for the number and ratio of the AST normal level at 2, 4, 6 weeks., week 2, 4, 6|ALT normalization time, It presents the time to normalize the ALT of the test group and the control group, and checks the difference between the test group and the control group using the log order test., during 6 week|The Rate of participants with ≤ 20% decrease of ALT relative to baseline at 2, 4 weeks, Check the difference by conducting Chi-Square Test or Fisher's Exact Test for the number and ratio of the ≤ 20% decrease of ALT relative to baseline at 2, 4, 6 weeks., week 2, 4, 6|Change in FSS score relative to baseline at 6 weeks, In order to compare the test groups and control groups, check the FSS change after 6 week compared to the baseline.

For the 6 week FSS 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., week 6