Overview

This trial is active, not recruiting.

Condition evidence of liver transplantation
Treatment eglandin
Phase phase 2
Sponsor Asan Medical Center
Start date March 2015
End date December 2017
Trial size 76 participants
Trial identifier NCT02350218, LSI-2014-0624

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Eglandin® (Alprostadil) 720㎍
eglandin Alprostadil
Inject Eglandin 360㎍ or 720㎍ for 14 days in living donor liver transplanted patient
(Active Comparator)
Eglandin® (Alprostadil) 360㎍
eglandin Alprostadil
Inject Eglandin 360㎍ or 720㎍ for 14 days in living donor liver transplanted patient

Primary Outcomes

Measure
Peak AST level within 7 days of Eglandin administration
time frame: 7 days

Secondary Outcomes

Measure
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
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)

Eligibility Criteria

Male or female participants from 19 years up to 65 years old.

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

Additional Information

Official title Open-label, Single Center, Randomized Clinical Trial to Evaluate Safety, Efficacy of Eglandin® (Alprostadil) 360㎍, 720㎍ in Living Donor Liver Transplanted Patient
Principal investigator Giwon Song, Professor
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Asan Medical Center.