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

Sponsor
Asan Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02350218
Collaborator
(none)
76
Enrollment
1
Location
2
Arms
45
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open-label, Single Center, Randomized Clinical Trial to Evaluate Safety, Efficacy of Eglandin® (Alprostadil) 360㎍, 720㎍ in Living Donor Liver Transplanted Patient
Study Start Date :
Mar 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Peak AST level within 7 days of Eglandin administration [7 days]

    Secondary Outcome Measures

    1. Area Under the Curve (AUC) of serum AST level within 5 days of Eglandin administration [5 days]

    2. Absolute and relative (percent) change in peak AST level within 7 days of Eglandin administration from baseline [7 days]

    3. Peak ALT levels within 7 days of Eglandin administration [7 days]

    4. 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]

    5. 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]

    6. 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]

    7. Time to total bilirubin recovery (within reference range) [day 2~14, day 30, 60,90, 120,150,180 from first dose of Eglandin administration]

    8. Transplant liver survival rate on Day 180 [Day 180]

    9. Incidence of hepatic artery/vein/portal thrombosis on Day 180 [Day 180]

    10. Safety (other laboratory test, vital sign, adverse event) evaluation [All visit(Screening, baseline, day 2~14, day 30, 60,90, 120,150,180)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Korea, Republic of Seoul Korea, Republic of 138-736

    Sponsors and Collaborators

    • Asan Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Giwon Song, Professor, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT02350218
    Other Study ID Numbers:
    • LSI-2014-0624
    First Posted:
    Jan 29, 2015
    Last Update Posted:
    Jul 6, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Giwon Song, Professor, Asan Medical Center
    Transplantation
    Living donor
    Eglandin
    Alprostadil
    Additional relevant MeSH terms:
    Alprostadil

    Study Results

    No Results Posted as of Jul 6, 2018