search
Back to results

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.

Primary Purpose

Chronic Liver Disease

Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LAENNEC (Human Placenta Hydrolysate)
normal saline
Sponsored by
Green Cross Wellbeing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Liver Disease

Eligibility Criteria

19 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Keimyung university dongsan medical centerRecruiting
  • Yeungnam universityRecruiting
  • Hanyang University Hospital.Recruiting
  • Korea university guro hospitalRecruiting
  • Severance hospitalRecruiting
  • Soonchunhyang university hospitalRecruiting
  • Wonju severance christian hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

Part A: LAENNEC 4ml

Part A: LAENNEC 6ml

Part A: LAENNEC 10ml

Part A: Normal Saline

Part B: LAENNEC 1

Part B: LAENNEC 2

Part B: Normal Saline

Arm Description

Dosing twice a week for 2 weeks

Dosing twice a week for 2 weeks

Dosing twice a week for 2 weeks

Dosing twice a week for 2 weeks

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

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

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

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.
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).
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).
PartB: Major liver function test (ALT, AST, γ-GT, total bilirubin)
Change amoust of ALT, AST, γ-GT, total bilirubin. Independent Two Sample T-Test compares the difference between the group

Full Information

First Posted
September 1, 2022
Last Updated
January 31, 2023
Sponsor
Green Cross Wellbeing
search

1. Study Identification

Unique Protocol Identification Number
NCT05532124
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Wellbeing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
49 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A: LAENNEC 4ml
Arm Type
Experimental
Arm Description
Dosing twice a week for 2 weeks
Arm Title
Part A: LAENNEC 6ml
Arm Type
Experimental
Arm Description
Dosing twice a week for 2 weeks
Arm Title
Part A: LAENNEC 10ml
Arm Type
Experimental
Arm Description
Dosing twice a week for 2 weeks
Arm Title
Part A: Normal Saline
Arm Type
Active Comparator
Arm Description
Dosing twice a week for 2 weeks
Arm Title
Part B: LAENNEC 1
Arm Type
Experimental
Arm Description
It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.
Arm Title
Part B: LAENNEC 2
Arm Type
Experimental
Arm Description
It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.
Arm Title
Part B: Normal Saline
Arm Type
Active Comparator
Arm Description
It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT.
Intervention Type
Biological
Intervention Name(s)
LAENNEC (Human Placenta Hydrolysate)
Intervention Description
Intravenous Injection
Intervention Type
Other
Intervention Name(s)
normal saline
Intervention Description
Intravenous Injection
Primary Outcome Measure Information:
Title
PartA: Adverse Event and clinical trials test
Description
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).
Time Frame
week 2
Title
PartB: Change amoust of ALT
Description
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.
Time Frame
week 6
Secondary Outcome Measure Information:
Title
PartA: Change amoust of ALT
Description
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.
Time Frame
week 2, 4 and 6
Title
PartA: Adverse Event and clinical trials test
Description
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).
Time Frame
week 6
Title
PartB: Adverse Event and clinical trials test
Description
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).
Time Frame
week 6
Title
PartB: Major liver function test (ALT, AST, γ-GT, total bilirubin)
Description
Change amoust of ALT, AST, γ-GT, total bilirubin. Independent Two Sample T-Test compares the difference between the group
Time Frame
week 2, 4 and 6
Other Pre-specified Outcome Measures:
Title
PartA: Fat liver decrease effect (MRS)
Description
Absolute change from baseline in mean liver fat (MRS) Independent Two Sample T-Test compares the difference between the group
Time Frame
week 6
Title
PartB: Fat liver decrease effect (MRS)
Description
Absolute change from baseline in mean liver fat (MRS) Independent Two Sample T-Test compares the difference between the group
Time Frame
week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At the time of screening, 18 or 75 years Those who have been diagnosed with alcoholic or non -alcoholic fatty liver disease and have persisted for more than 6 months Those who are 1.5 times (60 IU/L) of the ALT level of Baseline (60 IU/L) A person who can complete the signature agreement and compliance the requirements for clinical trials. Exclusion Criteria: Liver function abnormalities caused by the following cause disease: viral hepatitis, biliary obstructions, autoimmune hepatitis, wilson disease, hematoprive Drug allergic symptoms (oscillation, heat, itching) Those with systemic infection (including tuberculosis) 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. Those who have experienced use of human -derived medicines within 6 months before selecting a test subject Those who have received other clinical drugs within 3 months before selecting a test subject Magnetic Resonance Spectroscopy (MRS) is impossible 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) Those who cannot inject intravenous infusions Those who judged that other testors were inappropriate as clinical trials
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yeongmin Kwon
Phone
+82-70-8892-7881
Email
ymkwon@gccorp.com
Facility Information:
Facility Name
Keimyung university dongsan medical center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Seok Hwang, Ph.D.
Facility Name
Yeungnam university
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Gil Park, Ph. D
Facility Name
Hanyang University Hospital.
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dae Won Jun, Ph D
Facility Name
Korea university guro hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji hoon Kim, Ph D
Facility Name
Severance hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Up Kim, Ph D
Facility Name
Soonchunhyang university hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Young Jang, Ph D
Facility Name
Wonju severance christian hospital
City
Wŏnju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moon Young Kim, Ph D

12. IPD Sharing Statement

Learn more about this trial

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.

We'll reach out to this number within 24 hrs