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Status unknownNCT02350218PROVISIONUpdated Jul 6, 2018

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

A Phase 2 interventional study of Eglandin in Evidence of Liver Transplantation, sponsored by Asan Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-07-06.

Sponsored by Asan Medical Center · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Evidence of Liver Transplantation

Keywords

  • Transplantation
  • Living donor
  • Eglandin
  • Alprostadil
03

In context

Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    Eglandin 720㎍

    Eglandin® (Alprostadil) 720㎍

    Drug: Eglandin

  • Active comparator
    Eglandin 360㎍

    Eglandin® (Alprostadil) 360㎍

    Drug: Eglandin

Interventions

  • DrugEglandin

    Inject Eglandin 360㎍ or 720㎍ for 14 days in living donor liver transplanted patient

    Also known as: Alprostadil

06

What researchers measure

Primary outcomes

  1. Peak AST level within 7 days of Eglandin administration

    Time frame: 7 days

Secondary outcomes

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

    Time frame: 5 days

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

    Time frame: 7 days

  3. Peak ALT levels within 7 days of Eglandin administration

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 7, 14, 30 and 60 days from first dose of Eglandin administration

  7. Time to total bilirubin recovery (within reference range)

    Time frame: day 2~14, day 30, 60,90, 120,150,180 from first dose of Eglandin administration

  8. Transplant liver survival rate on Day 180

    Time frame: Day 180

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

    Time frame: Day 180

  10. Safety (other laboratory test, vital sign, adverse event) evaluation

    Time frame: All visit(Screening, baseline, day 2~14, day 30, 60,90, 120,150,180)

07

Study locations

1 site
  • Korea, Republic of
    Seoul, 138-736, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02350218
Lead sponsor
Asan Medical Center
Responsible party
Giwon Song (Professor, Asan Medical Center) — Principal investigator
First posted
Jan 29, 2015
Start date
Mar 2015
Primary completion
Dec 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Jul 6, 2018

Study contacts

Giwon Song, Professor
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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