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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.

Phase 2
Recruiting
Conditions
Chronic Liver Disease
Interventions
Biological: LAENNEC (Human Placenta Hydrolysate)
Other: normal saline
Registration Number
NCT05532124
Lead Sponsor
Green Cross Wellbeing
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
49
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Part B: LAENNEC 1LAENNEC (Human Placenta Hydrolysate)It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.
Part A: Normal Salinenormal salineDosing twice a week for 2 weeks
Part B: Normal Salinenormal salineIt is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.
Part A: LAENNEC 6mlLAENNEC (Human Placenta Hydrolysate)Dosing twice a week for 2 weeks
Part A: LAENNEC 10mlLAENNEC (Human Placenta Hydrolysate)Dosing twice a week for 2 weeks
Part A: LAENNEC 4mlLAENNEC (Human Placenta Hydrolysate)Dosing twice a week for 2 weeks
Part B: LAENNEC 2LAENNEC (Human Placenta Hydrolysate)It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.
Primary Outcome Measures
NameTimeMethod
PartA: Adverse Event and clinical trials testweek 2

The ratio of the test subjects who have experienced more than one Adverse Event is compared with the Chi-Square Test or Fisher's Exact Test.

For clinical trial tests, the amount of change in the group is paired T-test, and the amount of changes between the groups is conducted with Independent Two Sample T-Test.

Mcnemar 's Test is performed for normal and abnormal changes in the administration of clinical trial tests, and the difference between the divisions between the group is performed with the Generalized Estimating Equation (GEE).

PartB: Change amoust of ALTweek 6

The ALT improvement rate of the test group and the control group is presented. The ALT proposes a ratio of test subjects that decreased by more than 20% compared to the base value, and compares the difference between the group using the Chi-Square Test or Fisher's Exact Test.

Secondary Outcome Measures
NameTimeMethod
PartB: Adverse Event and clinical trials testweek 6

The ratio of the test subjects who have experienced more than one Adverse Event is compared with the Chi-Square Test or Fisher's Exact Test.

For clinical trial tests, the amount of change in the group is paired T-test, and the amount of changes between the groups is conducted with Independent Two Sample T-Test.

Mcnemar 's Test is performed for normal and abnormal changes in the administration of clinical trial tests, and the difference between the divisions between the group is performed with the Generalized Estimating Equation (GEE).

PartA: Change amoust of ALTweek 2, 4 and 6

The ALT improvement rate of the test group and the control group is presented. The ALT proposes a ratio of test subjects that decreased by more than 20% compared to the base value, and compares the difference between the group using the Chi-Square Test or Fisher's Exact Test.

PartA: Adverse Event and clinical trials testweek 6

The ratio of the test subjects who have experienced more than one Adverse Event is compared with the Chi-Square Test or Fisher's Exact Test.

For clinical trial tests, the amount of change in the group is paired T-test, and the amount of changes between the groups is conducted with Independent Two Sample T-Test.

Mcnemar 's Test is performed for normal and abnormal changes in the administration of clinical trial tests, and the difference between the divisions between the group is performed with the Generalized Estimating Equation (GEE).

PartB: Major liver function test (ALT, AST, γ-GT, total bilirubin)week 2, 4 and 6

Change amoust of ALT, AST, γ-GT, total bilirubin.

Independent Two Sample T-Test compares the difference between the group

Trial Locations

Locations (7)

Severance hospital

🇰🇷

Seoul, Korea, Republic of

Soonchunhyang university hospital

🇰🇷

Seoul, Korea, Republic of

Wonju severance christian hospital

🇰🇷

Wŏnju, Korea, Republic of

Keimyung university dongsan medical center

🇰🇷

Daegu, Korea, Republic of

Yeungnam university

🇰🇷

Daegu, Korea, Republic of

Hanyang University Hospital.

🇰🇷

Seoul, Korea, Republic of

Korea university guro hospital

🇰🇷

Seoul, Korea, Republic of

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