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.
Chronic Liver Disease
About this trial
This is an interventional treatment trial for Chronic Liver Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Keimyung university dongsan medical centerRecruiting
- Yeungnam universityRecruiting
- Hanyang University Hospital.Recruiting
- Korea university guro hospitalRecruiting
- Severance hospitalRecruiting
- Soonchunhyang university hospitalRecruiting
- Wonju severance christian hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Active Comparator
Experimental
Experimental
Active Comparator
Part A: LAENNEC 4ml
Part A: LAENNEC 6ml
Part A: LAENNEC 10ml
Part A: Normal Saline
Part B: LAENNEC 1
Part B: LAENNEC 2
Part B: Normal Saline
Dosing twice a week for 2 weeks
Dosing twice a week for 2 weeks
Dosing twice a week for 2 weeks
Dosing twice a week for 2 weeks
It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.
It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.
It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.