Evidence of Liver Transplantation
Conditions
Keywords
Transplantation, Living donor, Eglandin, Alprostadil
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.
Interventions
DRUGEglandin
Inject Eglandin 360㎍ or 720㎍ for 14 days in living donor liver transplanted patient
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak AST level within 7 days of Eglandin administration | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Area Under the Curve (AUC) of serum AST level within 5 days of Eglandin administration | 5 days |
| 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) |
| 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 |
Countries
South Korea
Outcome results
None listed