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.

Green Cross Wellbeing

Status and phase: Enrolling; Phase 2

Conditions: Chronic Liver Disease

Treatments: Other: normal saline; Biological: LAENNEC (Human Placenta Hydrolysate)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05532124

LAEN-IV2A

Details and patient eligibility

About

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.

Enrollment: 49 estimated patients

Sex: All

Ages: 19 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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49 participants in 7 patient groups

Part A: LAENNEC 4ml

Experimental group

Description:

Dosing twice a week for 2 weeks

Treatment:

Biological: LAENNEC (Human Placenta Hydrolysate)

Part A: LAENNEC 6ml

Experimental group

Description:

Dosing twice a week for 2 weeks

Treatment:

Biological: LAENNEC (Human Placenta Hydrolysate)

Part A: LAENNEC 10ml

Experimental group

Description:

Dosing twice a week for 2 weeks

Treatment:

Biological: LAENNEC (Human Placenta Hydrolysate)

Part A: Normal Saline

Active Comparator group

Description:

Dosing twice a week for 2 weeks

Treatment:

Other: normal saline

Part B: LAENNEC 1

Experimental group

Description:

It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.

Treatment:

Biological: LAENNEC (Human Placenta Hydrolysate)

Part B: LAENNEC 2

Experimental group

Description:

It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.

Treatment:

Biological: LAENNEC (Human Placenta Hydrolysate)

Part B: Normal Saline

Active Comparator group

Description:

It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.

Treatment:

Other: normal saline