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

July 5, 2018 updated by: Giwon Song, Asan Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Peak AST level within 7 days of Eglandin administration
Time Frame: 7 days
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Area Under the Curve (AUC) of serum AST level within 5 days of Eglandin administration
Time Frame: 5 days
5 days
Absolute and relative (percent) change in peak AST level within 7 days of Eglandin administration from baseline
Time Frame: 7 days
7 days
Peak ALT levels within 7 days of Eglandin administration
Time Frame: 7 days
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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: day 2~14, day 30, 60,90, 120,150,180 from first dose of Eglandin administration
day 2~14, day 30, 60,90, 120,150,180 from first dose of Eglandin administration
Transplant liver survival rate on Day 180
Time Frame: Day 180
Day 180
Incidence of hepatic artery/vein/portal thrombosis on Day 180
Time Frame: Day 180
Day 180
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)
All visit(Screening, baseline, day 2~14, day 30, 60,90, 120,150,180)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Asan Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Giwon Song, Professor, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LSI-2014-0624

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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