Chronic Liver Disease
Conditions
Brief summary
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.
Interventions
BIOLOGICALLAENNEC (Human Placenta Hydrolysate)
Intravenous Injection
OTHERnormal saline
Intravenous Injection
Sponsors
Green Cross Wellbeing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. At the time of screening, 18 or 75 years 2. Those who have been diagnosed with alcoholic or non -alcoholic fatty liver disease and have persisted for more than 6 months 3. Those who are 1.5 times (60 IU/L) of the ALT level of Baseline (60 IU/L) 4. A person who can complete the signature agreement and compliance the requirements for clinical trials.
Exclusion criteria
1. Liver function abnormalities caused by the following cause disease: viral hepatitis, biliary obstructions, autoimmune hepatitis, wilson disease, hematoprive 2. Drug allergic symptoms (oscillation, heat, itching) 3. Those with systemic infection (including tuberculosis) 4. 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. 5. Those who have experienced use of human -derived medicines within 6 months before selecting a test subject 6. Those who have received other clinical drugs within 3 months before selecting a test subject 7. Magnetic Resonance Spectroscopy (MRS) is impossible 8. 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) 9. Those who cannot inject intravenous infusions 10. Those who judged that other testors were inappropriate as clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PartA: Adverse Event and clinical trials test | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PartA: Change amoust of ALT | week 2, 4 and 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. |
| PartA: Adverse Event and clinical trials test | week 6 | 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: Adverse Event and clinical trials test | week 6 | 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: Major liver function test (ALT, AST, γ-GT, total bilirubin) | week 2, 4 and 6 | Change amoust of ALT, AST, γ-GT, total bilirubin. Independent Two Sample T-Test compares the difference between the group |
Countries
South Korea
Outcome results
None listed