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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Alprostadil

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