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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: LAENNEC 4ml | Experimental | Dosing twice a week for 2 weeks |
|
| Part A: LAENNEC 6ml | Experimental | Dosing twice a week for 2 weeks |
|
| Part A: LAENNEC 10ml | Experimental | Dosing twice a week for 2 weeks |
|
| Part A: Normal Saline | Active Comparator | Dosing twice a week for 2 weeks |
|
| Part B: LAENNEC 1 | Experimental | It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT. |
|
| Part B: LAENNEC 2 | Experimental | It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAENNEC (Human Placenta Hydrolysate) | Biological | Intravenous Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| PartB: Fat liver decrease effect (MRS) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keimyung university dongsan medical center | Daegu | South Korea | ||||
| Yeungnam university |
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|
| Part B: Normal Saline | Active Comparator | It is administered twice a week or placebo, and administered until it is normalized for up to 6 weeks or ALT. |
|
| normal saline | Other | Intravenous Injection |
|
| 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 |
| 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 |
| 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 | week 2, 4 and 6 |
Absolute change from baseline in mean liver fat (MRS)
Independent Two Sample T-Test compares the difference between the group
| week 6 |
| 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 |
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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