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

Asan Medical Center

Status and phase: Unknown; Phase 2

Conditions: Evidence of Liver Transplantation

Treatments: Drug: Eglandin

Study type: Interventional

Funder types: Other

Identifiers

NCT02350218

LSI-2014-0624

Details and patient eligibility

About

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Eglandin 720㎍

Experimental group

Description:

Eglandin® (Alprostadil) 720㎍

Treatment:

Drug: Eglandin

Eglandin 360㎍

Active Comparator group

Description:

Eglandin® (Alprostadil) 360㎍

Treatment:

Drug: Eglandin