Safety, Efficacy of Eglandin® in Living Donor Liver Transplanted Patient (PROVISION)

Study Overview
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Brief Summary
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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.

Official Title
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Open-label, Single Center, Randomized Clinical Trial to Evaluate Safety, Efficacy of Eglandin® (Alprostadil) 360㎍, 720㎍ in Living Donor Liver Transplanted Patient

Conditions
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Evidence of Liver Transplantation

Intervention / Treatment
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* Drug: Eglandin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary living donor liver transplantation Patient received modified right lobe graft Aged between 19 to 65 years Informed consent Exclusion Criteria: ABO incompatibility Dual liver transplant patient from 2 donors History of liver transplantation or other organ transplantation Transplantation of other organ(s) at the time of liver transplantation Use of artificial liver device prior to liver transplantation UNOS status Ⅰor ⅡA History of malignant tumor within 5 years Not included in Milan liver transplant criteria for hepatocellular carcinoma Patient with WBC < 2,000/mm3 or ANC < 900/mm3 or platelet < 30,000/mm3 at the time of screening Patient exposed to severe systemic infection requiring treatment Positive response for HIV in either donor or recipient Prior administration of other investigational product within 30 days (or 5 times the half life) from date of screening Women of childbearing age without effective contraception, breast feeding and pregnant women Substance abuser, patient with metal disorder, and otherwise legally not eligible patient Not eligible to participate at discrete of study investigator

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eglandin 720㎍<br>Eglandin® (Alprostadil) 720㎍ | Drug: Eglandin<br>* Inject Eglandin 360㎍ or 720㎍ for 14 days in living donor liver transplanted patient<br>* Other names: Alprostadil;|
| Active Comparator: Eglandin 360㎍<br>Eglandin® (Alprostadil) 360㎍ | Drug: Eglandin<br>* Inject Eglandin 360㎍ or 720㎍ for 14 days in living donor liver transplanted patient<br>* Other names: Alprostadil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak AST level within 7 days of Eglandin administration |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transplantation, Living donor, Eglandin, Alprostadil