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

NCT02350218 | Unknown Phase 2 DMC

• 1 other identifier: LSI-2014-0624
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Evidence of Liver Transplantation

Keywords

Transplantation; Living donor; Eglandin; Alprostadil

Outcome Measures

Primary Outcomes (1)

• Peak AST level within 7 days of Eglandin administration

  7 days

Secondary Outcomes (10)

• 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

Study Arms (2)

Eglandin 720㎍

EXPERIMENTAL

Eglandin® (Alprostadil) 720㎍

Drug: Eglandin

Eglandin 360㎍

ACTIVE COMPARATOR

Eglandin® (Alprostadil) 360㎍

Drug: Eglandin

Interventions

Eglandin DRUG

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

Also known as: Alprostadil

Eglandin 360㎍; Eglandin 720㎍

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary living donor liver transplantation
• Patient received modified right lobe graft
• Aged between 19 to 65 years
• Informed consent

You may not qualify if:

• ABO incompatibility
• Dual liver transplant patient from 2 donors
• History of liver transplantation or other organ transplantation
• Transplantation of other organ(s) at the time of liver transplantation
• Use of artificial liver device prior to liver transplantation
• UNOS status Ⅰor ⅡA
• History of malignant tumor within 5 years
• Not included in Milan liver transplant criteria for hepatocellular carcinoma
• Patient with WBC \< 2,000/mm3 or ANC \< 900/mm3 or platelet \< 30,000/mm3 at the time of screening
• Patient exposed to severe systemic infection requiring treatment
• Positive response for HIV in either donor or recipient
• Prior administration of other investigational product within 30 days (or 5 times the half life) from date of screening
• Women of childbearing age without effective contraception, breast feeding and pregnant women
• Substance abuser, patient with metal disorder, and otherwise legally not eligible patient
• Not eligible to participate at discrete of study investigator

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Korea, Republic of

Seoul, 138-736, South Korea

Location

MeSH Terms

Interventions

Alprostadil

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Giwon Song, Professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: January 29, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 6, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)