Control group : LAENNEC subcutaneous injection (4 ml) Experimental group : LAENNEC intravenous injection (10 ml)
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
226
Intravenous Injection
Subcutaneous Injection
GC wellbeing
Yongin-si, South Korea
RECRUITINGChange 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.
Time frame: week 6
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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 6