NCT01481974

Brief Summary

The overall purpose of this study is to evaluate the safety, pharmacokinetics and preliminary efficacy of a five-days post-operative course of Treprostinil in liver transplant patients. The hypothesis of this study is that Treprostinil can be safely administered post-operatively in liver transplant patients. Once safety is documented future studies will address its ability to ameliorate or prevent reperfusion mediated dysfunction of the liver graft and thereby reduce morbidity, leading to shorter hospital stays as compared to historical controls.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2012

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
1 year until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2019

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

6.5 years

First QC Date

October 20, 2011

Last Update Submit

December 8, 2023

Conditions

Ischemia Reperfusion Injury

Keywords

liver transplantationtreprostinil

Outcome Measures

Primary Outcomes (1)

  • Serum ALT concentration after treprostinil treatment in liver transplant patients

    The liver injury marker such as alanine aminotransferase (ALT) will be measured in order to evaluate the protective effect of treprostinil in liver transplant recipients.

    Day 7

Secondary Outcomes (1)

  • Pharmacokinetics of treprostinil in liver transplant patients

    0, 2, 4, 6, 12, 18, 24, 30, 36, 42, 48, 72, 96 and 120 hrs during therapy and approximately 0.5, 1, 2, 4, 6, 8, 12 and 24 hr post study drug termination

Study Arms (1)

Treprostinil

EXPERIMENTAL

This is a single center, open-label, dose-escalation Phase I/II study of Treprostinil.

Drug: Treprostinil

Interventions

TreprostinilDRUG

The Treatment Phase will begin at the initiation of Treprostinil after induction of anesthesia for the transplant surgery and continues throughout the surgery and for approximately a total of 120 hours. Treatment phase activities include: • Initiation of Treprostinil after the patient is hemodynamically stable following transplant surgery. (Treprostinil dosing will follow a standard 3 + 3 phase 1 design.

Also known as: Brand name: REMODULIN
Treprostinil

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have signed appropriate informed consent.
  • Be between 18 years and 65 years of age.
  • Have been accepted as a liver transplant candidate at the University of Pittsburgh Medical center (UPMC).
  • Be receiving a cadaver donor liver transplant.
  • Be treated in accordance with the standard of care protocol(s) currently in effect for liver transplant recipients at the UPMC, including immunosuppression and other elements of pre- and post-operative care.

You may not qualify if:

  • Subjects must not:
  • Be receiving a living donor liver transplant.
  • Be receiving a donor liver with a cold ischemia time less than 5 hours or greater than 12 hours.
  • Be receiving any investigational drug (a drug other than Treprostinil administered under an IND) or participating in any other investigational study, with the exception of alemtuzumab (Campath).
  • Be receiving any prostanoid to treat portopulmonary hypertension.
  • Have had a failed liver transplant within the previous 180 days.
  • Be undergoing multi-organ transplantation (transplantation of organs other than liver at the same time as the liver transplantation procedure).
  • Have fulminant hepatic failure
  • Model for end stage liver diseases (MELD) score of \> 40
  • Hepatitis C positive donor liver
  • On renal replacement therapy at the time of study
  • Be receiving any non-standard immunosuppression protocol or other non-standard treatment that could affect interpretation of the study results.
  • Those currently receiving treatment for portopulmonary hypertension.
  • Those with significant cardiovascular disease including treatment with inotropes.
  • Have any known hypersensitivity to prostaglandins, prostacyclin or treprostinil.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Abhinav Humar

Pittsburgh, Pennsylvania, 15261, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Reperfusion Injury

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Abhinav Humar, M.D.

    University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 20, 2011

First Posted

November 30, 2011

Study Start

December 1, 2012

Primary Completion

May 18, 2019

Study Completion

November 24, 2019

Last Updated

December 15, 2023

Record last verified: 2023-12

Locations

US(2)