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

Open-label, Single Center, Randomized Clinical Trial to Evaluate Safety, Efficacy of Eglandin® (Alprostadil) 360㎍, 720㎍ in Living Donor Liver Transplanted Patient

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.

Study Overview

• Status: Unknown
• Conditions: Evidence of Liver Transplantation
• Intervention / Treatment: Drug: Eglandin

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eglandin 720㎍; Eglandin® (Alprostadil) 720㎍	Drug: Eglandin; Inject Eglandin 360㎍ or 720㎍ for 14 days in living donor liver transplanted patient; Other Names: Alprostadil
Active Comparator: Eglandin 360㎍; Eglandin® (Alprostadil) 360㎍	Drug: Eglandin; Inject Eglandin 360㎍ or 720㎍ for 14 days in living donor liver transplanted patient; Other Names: Alprostadil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak AST level within 7 days of Eglandin administration	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Area Under the Curve (AUC) of serum AST level within 5 days of Eglandin administration	5 days
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
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
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)

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Giwon Song, Professor, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: January 20, 2015
• First Submitted That Met QC Criteria: January 25, 2015
• First Posted (Estimate): January 29, 2015

Study Record Updates

• Last Update Posted (Actual): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 5, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Transplantation; Alprostadil; Living donor; Eglandin
• Additional Relevant MeSH Terms: Vasodilator Agents; Urological Agents; Platelet Aggregation Inhibitors; Alprostadil
• Other Study ID Numbers: LSI-2014-0624

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO