Clinical trial NCT02350218: Safety, Efficacy of Eglandin® in Living Donor Liver Transplanted Patient (PROVISION)
Official title: Open-label, Single Center, Randomized Clinical Trial to Evaluate Safety, Efficacy of Eglandin® (Alprostadil) 360㎍, 720㎍ in Living Donor Liver Transplanted Patient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Evidence of Liver Transplantation
Keywords: Transplantation
Living donor
Eglandin
Alprostadil
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 76
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Primary living donor liver transplantation
2. Patient received modified right lobe graft
3. Aged between 19 to 65 years
4. Informed consent

Exclusion Criteria:

1. ABO incompatibility
2. Dual liver transplant patient from 2 donors
3. History of liver transplantation or other organ transplantation
4. Transplantation of other organ(s) at the time of liver transplantation
5. Use of artificial liver device prior to liver transplantation
6. UNOS status Ⅰor ⅡA
7. History of malignant tumor within 5 years
8. Not included in Milan liver transplant criteria for hepatocellular carcinoma
9. Patient with WBC \< 2,000/mm3 or ANC \< 900/mm3 or platelet \< 30,000/mm3 at the time of screening
10. Patient exposed to severe systemic infection requiring treatment
11. Positive response for HIV in either donor or recipient
12. Prior administration of other investigational product within 30 days (or 5 times the half life) from date of screening
13. Women of childbearing age without effective contraception, breast feeding and pregnant women
14. Substance abuser, patient with metal disorder, and otherwise legally not eligible patient
15. Not eligible to participate at discrete of study investigator

Primary outcomes:
measure: Peak AST level within 7 days of Eglandin administration
timeFrame: 7 days
Secondary outcomes:
measure: Area Under the Curve (AUC) of serum AST level within 5 days of Eglandin administration
timeFrame: 5 days
measure: Absolute and relative (percent) change in peak AST level within 7 days of Eglandin administration from baseline
timeFrame: 7 days
measure: Peak ALT levels within 7 days of Eglandin administration
timeFrame: 7 days
measure: 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
timeFrame: 7th, 14th, 60th, and 120th day from first dose of Eglandin administration
measure: Change in total bilirubin/AST/ALT from baseline at 7th, 14th, 30th, and 60th day from first dose of Eglandin administration
timeFrame: 7th, 14th, 30th, and 60th day from first dose of Eglandin administration
measure: Peak total bilirubin levels within 7, 14, 30 and 60 days from first dose of Eglandin administration
timeFrame: 7, 14, 30 and 60 days from first dose of Eglandin administration
measure: Time to total bilirubin recovery (within reference range)
timeFrame: day 2~14, day 30, 60,90, 120,150,180 from first dose of Eglandin administration
measure: Transplant liver survival rate on Day 180
timeFrame: Day 180
measure: Incidence of hepatic artery/vein/portal thrombosis on Day 180
timeFrame: Day 180
measure: Safety (other laboratory test, vital sign, adverse event) evaluation
timeFrame: All visit(Screening, baseline, day 2~14, day 30, 60,90, 120,150,180)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea, Republic of
Study officials:
affiliation: Asan Medical Center
name: Giwon Song, Professor
role: PRINCIPAL_INVESTIGATOR
References: