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The purpose of this study is to evaluate superiority of Eglandin® (Alprostadil) 720㎍compared to 360㎍ in terms of safety, efficacy in living donor liver transplant patient, peak AST levels followed by Eglandin administration were assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eglandin 720㎍ | Experimental | Eglandin® (Alprostadil) 720㎍ |
|
| Eglandin 360㎍ | Active Comparator | Eglandin® (Alprostadil) 360㎍ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eglandin | Drug | Inject Eglandin 360㎍ or 720㎍ for 14 days in living donor liver transplanted patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak AST level within 7 days of Eglandin administration | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) of serum AST level within 5 days of Eglandin administration | 5 days | |
| Absolute and relative (percent) change in peak AST level within 7 days of Eglandin administration from baseline | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giwon Song, Professor | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea, Republic of | Seoul | 138-736 | South Korea |
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| ID | Term |
|---|---|
| D000527 | Alprostadil |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Peak ALT levels within 7 days of Eglandin administration | 7 days |
| Change in blood flow rate of hepatic artery/vein/portal from baseline at 7th, 14th, 60th, and 120th day from first dose of Eglandin administration | 7th, 14th, 60th, and 120th day from first dose of Eglandin administration |
| Change in total bilirubin/AST/ALT from baseline at 7th, 14th, 30th, and 60th day from first dose of Eglandin administration | 7th, 14th, 30th, and 60th day from first dose of Eglandin administration |
| Peak total bilirubin levels within 7, 14, 30 and 60 days from first dose of Eglandin administration | 7, 14, 30 and 60 days from first dose of Eglandin administration |
| Time to total bilirubin recovery (within reference range) | day 2~14, day 30, 60,90, 120,150,180 from first dose of Eglandin administration |
| Transplant liver survival rate on Day 180 | Day 180 |
| Incidence of hepatic artery/vein/portal thrombosis on Day 180 | Day 180 |
| Safety (other laboratory test, vital sign, adverse event) evaluation | All visit(Screening, baseline, day 2~14, day 30, 60,90, 120,150,180) |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D005229 | Fatty Acids, Monounsaturated |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |