Clinical trial NCT05532124: 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.
Official title: LAENNEC (Human Placenta Hydrolysate) Stiffness of Chronic Liver Disease Patients to Evaluate the Safety and Effectiveness of Multi -Tube, Eye, Placebo, and Capacity Increase and Capacity Enlargement Clinical Trial to Assess the Safety and Effectiveness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Liver Disease
Lead sponsor: Green Cross Wellbeing
Sponsor class: INDUSTRY
First posted: 2022-09-08
Enrollment: 49
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: PartA: Adverse Event and clinical trials test
timeFrame: week 2
measure: PartB: Change amoust of ALT
timeFrame: week 6
Secondary outcomes:
measure: PartA: Change amoust of ALT
timeFrame: week 2, 4 and 6
measure: PartA: Adverse Event and clinical trials test
timeFrame: week 6
measure: PartB: Adverse Event and clinical trials test
timeFrame: week 6
measure: PartB: Major liver function test (ALT, AST, γ-GT, total bilirubin)
timeFrame: week 2, 4 and 6
Other outcomes:
measure: PartA: Fat liver decrease effect (MRS)
timeFrame: week 6
measure: PartB: Fat liver decrease effect (MRS)
timeFrame: week 6
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung university dongsan medical center
city: Daegu
country: Korea, Republic of
facility: Yeungnam university
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital.
city: Seoul
country: Korea, Republic of
facility: Korea university guro hospital
city: Seoul
country: Korea, Republic of
facility: Severance hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang university hospital
city: Wŏnju
country: Korea, Republic of
facility: Wonju severance christian hospital
Study officials:
References: