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

Phase 2

• Conditions: Evidence of Liver Transplantation
• Interventions: Drug: Eglandin

• Registration Number: NCT02350218
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-20
• Study First Submitted QC: 2015-01-25
• Study First Posted: 2015-01-29
• Study Start: 2015-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-05
• Last Update Posted: 2018-07-06
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eglandin 720㎍	Eglandin	Eglandin® (Alprostadil) 720㎍
Eglandin 360㎍	Eglandin	Eglandin® (Alprostadil) 360㎍

Primary Outcome Measures

Name	Time	Method
Peak AST level within 7 days of Eglandin administration	7 days

Secondary Outcome Measures

Name	Time	Method
Time to total bilirubin recovery (within reference range)	day 2~14, day 30, 60,90, 120,150,180 from first dose of Eglandin administration
Area Under the Curve (AUC) of serum AST level within 5 days of Eglandin administration	5 days
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)
Absolute and relative (percent) change in peak AST level within 7 days of Eglandin administration from baseline	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
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
Peak ALT levels within 7 days of Eglandin administration	7 days

Trial Locations

Locations (1)

Korea, Republic of; 🇰🇷 Seoul, Korea, Republic of