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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
49
Intravenous Injection
Intravenous Injection
Keimyung university dongsan medical center
Daegu, South Korea
Yeungnam university
Daegu, South Korea
Hanyang University Hospital.
Seoul, South Korea
Korea university guro hospital
Seoul, South Korea
PartA: Adverse Event and clinical trials test
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).
Time frame: week 2
PartB: Change amoust of ALT
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.
Time frame: week 6
PartA: Change amoust of ALT
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.
Time frame: week 2, 4 and 6
PartA: Adverse Event and clinical trials test
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).
Time frame: week 6
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Severance hospital
Seoul, South Korea
Soonchunhyang university hospital
Seoul, South Korea
Wonju severance christian hospital
Wŏnju, South Korea
PartB: Adverse Event and clinical trials test
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).
Time frame: week 6
PartB: Major liver function test (ALT, AST, γ-GT, total bilirubin)
Change amoust of ALT, AST, γ-GT, total bilirubin. Independent Two Sample T-Test compares the difference between the group
Time frame: week 2, 4 and 6