Part A: In Patients With Chronic Liver Diseases, LAENNEC (Human Placenta Hydrolysate) is to Asses… (NCT05532124) | Clinical Trial Compass
CompletedPhase 2
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.
South Korea49 participantsStarted 2021-06-01
Plain-language 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.
Who can participate
Age range19 Years – 74 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)