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.

Chronic Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05532124
• Other study ID #: LAEN-IV2A
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2021
• Est. completion date: June 2023

Study information

• Verified date: September 2022
• Source: Green Cross Wellbeing
• Contact: Yeongmin Kwon
• Phone: +82-70-8892-7881
• Email: ymkwon[@]gccorp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 49
• Est. completion date: June 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases

Intervention

Biological:
• LAENNEC (Human Placenta Hydrolysate)
Intravenous Injection

Other:
• normal saline
Intravenous Injection

Locations

Country	Name	City	State
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	Severance hospital	Seoul
Korea, Republic of	Soonchunhyang university hospital	Seoul
Korea, Republic of	Wonju severance christian hospital	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Wellbeing

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PartA: Fat liver decrease effect (MRS)	Absolute change from baseline in mean liver fat (MRS); Independent Two Sample T-Test compares the difference between the group	week 6
Other	PartB: Fat liver decrease effect (MRS)	Absolute change from baseline in mean liver fat (MRS); Independent Two Sample T-Test compares the difference between the group	week 6
Primary	PartA: Adverse Event and clinical trials test	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).	week 2
Primary	PartB: Change amoust of ALT	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.	week 6
Secondary	PartA: Change amoust of ALT	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.	week 2, 4 and 6
Secondary	PartA: Adverse Event and clinical trials test	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).	week 6
Secondary	PartB: Adverse Event and clinical trials test	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).	week 6
Secondary	PartB: Major liver function test (ALT, AST, ?-GT, total bilirubin)	Change amoust of ALT, AST, ?-GT, total bilirubin.; Independent Two Sample T-Test compares the difference between the group	week 2, 4 and 6