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.
- Conditions
- Chronic Liver Disease
- Interventions
- Biological: LAENNEC (Human Placenta Hydrolysate)Other: normal saline
- Registration Number
- NCT05532124
- Lead Sponsor
- Green Cross Wellbeing
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 49
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part B: LAENNEC 1 LAENNEC (Human Placenta Hydrolysate) It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT. Part A: Normal Saline normal saline Dosing twice a week for 2 weeks Part B: Normal Saline normal saline It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT. Part A: LAENNEC 6ml LAENNEC (Human Placenta Hydrolysate) Dosing twice a week for 2 weeks Part A: LAENNEC 10ml LAENNEC (Human Placenta Hydrolysate) Dosing twice a week for 2 weeks Part A: LAENNEC 4ml LAENNEC (Human Placenta Hydrolysate) Dosing twice a week for 2 weeks Part B: LAENNEC 2 LAENNEC (Human Placenta Hydrolysate) It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).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: 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
Trial Locations
- Locations (7)
Severance hospital
🇰🇷Seoul, Korea, Republic of
Soonchunhyang university hospital
🇰🇷Seoul, Korea, Republic of
Wonju severance christian hospital
🇰🇷Wŏnju, Korea, Republic of
Keimyung university dongsan medical center
🇰🇷Daegu, Korea, Republic of
Yeungnam university
🇰🇷Daegu, Korea, Republic of
Hanyang University Hospital.
🇰🇷Seoul, Korea, Republic of
Korea university guro hospital
🇰🇷Seoul, Korea, Republic of