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.
NCT ID: NCT05532124
Last Updated: 2023-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
49 participants
INTERVENTIONAL
2021-06-01
2023-06-30
Brief Summary
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Part B: Part A, it is to Determine the Optimal Dose by Evaluating Two Capacity and Placebo Groups.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part A: LAENNEC 4ml
Dosing twice a week for 2 weeks
LAENNEC (Human Placenta Hydrolysate)
Intravenous Injection
Part A: LAENNEC 6ml
Dosing twice a week for 2 weeks
LAENNEC (Human Placenta Hydrolysate)
Intravenous Injection
Part A: LAENNEC 10ml
Dosing twice a week for 2 weeks
LAENNEC (Human Placenta Hydrolysate)
Intravenous Injection
Part A: Normal Saline
Dosing twice a week for 2 weeks
normal saline
Intravenous Injection
Part B: LAENNEC 1
It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.
LAENNEC (Human Placenta Hydrolysate)
Intravenous Injection
Part B: LAENNEC 2
It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.
LAENNEC (Human Placenta Hydrolysate)
Intravenous Injection
Part B: Normal Saline
It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.
normal saline
Intravenous Injection
Interventions
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LAENNEC (Human Placenta Hydrolysate)
Intravenous Injection
normal saline
Intravenous Injection
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
74 Years
ALL
No
Sponsors
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Green Cross Wellbeing
INDUSTRY
Responsible Party
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Locations
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Keimyung university dongsan medical center
Daegu, , South Korea
Yeungnam university
Daegu, , South Korea
Hanyang University Hospital.
Seoul, , South Korea
Korea university guro hospital
Seoul, , South Korea
Severance hospital
Seoul, , South Korea
Soonchunhyang university hospital
Seoul, , South Korea
Wonju severance christian hospital
Wŏnju, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Jae Seok Hwang, Ph.D.
Role: primary
Jung Gil Park, Ph. D
Role: primary
Dae Won Jun, Ph D
Role: primary
Ji hoon Kim, Ph D
Role: primary
Seung Up Kim, Ph D
Role: primary
Jae Young Jang, Ph D
Role: primary
Moon Young Kim, Ph D
Role: primary
Other Identifiers
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LAEN-IV2A
Identifier Type: -
Identifier Source: org_study_id
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