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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Inject Eglandin 360㎍ or 720㎍ for 14 days in living donor liver transplanted patient
Korea, Republic of
Seoul, South Korea
Peak AST level within 7 days of Eglandin administration
Time frame: 7 days
Area Under the Curve (AUC) of serum AST level within 5 days of Eglandin administration
Time frame: 5 days
Absolute and relative (percent) change in peak AST level within 7 days of Eglandin administration from baseline
Time frame: 7 days
Peak ALT levels within 7 days of Eglandin administration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 7, 14, 30 and 60 days from first dose of Eglandin administration
Time to total bilirubin recovery (within reference range)
Time frame: day 2~14, day 30, 60,90, 120,150,180 from first dose of Eglandin administration
Transplant liver survival rate on Day 180
Time frame: Day 180
Incidence of hepatic artery/vein/portal thrombosis on Day 180
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Time frame: Day 180
Safety (other laboratory test, vital sign, adverse event) evaluation
Time frame: All visit(Screening, baseline, day 2~14, day 30, 60,90, 120,150,180)