NCT01292824

Brief Summary

This is a phase I pilot study to determine the safety and preliminary efficacy of a novel hepatitis C virus (HCV) entry inhibitor (ITX 5061) in patients with HCV infection undergoing liver transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

1.9 years

First QC Date

February 9, 2011

Last Update Submit

December 1, 2015

Conditions

Hepatitis CEvidence of Liver Transplantation

Keywords

Hepatitis C virusEntryScavenger receptor-BIHigh density lipoproteinLiver transplantation

Outcome Measures

Primary Outcomes (1)

  • To determine the safety of ITX 5061 in liver transplant recipients

    Safety will be assessed by determination of the frequency of: * perioperative events: including transfusion requirements and vasopressor requirements * post-operative events: including primary graft non-function, hepatic artery thrombosis, acute cellular rejection and infective complications

    90 days

Secondary Outcomes (2)

  • To determine whether treatment leads to an alteration in HCV RNA kinetics in the first week after liver transplantation

    One week

  • To determine whether any change in early viral kinetics is sustained

    90 days

Study Arms (2)

Standard liver transplant care

NO INTERVENTION

Liver Transplantation as per Standard of Care

ITX 5061

EXPERIMENTAL

Liver Transplantation as per Standard of Care + ITX5061

Drug: ITX 5061

Interventions

ITX 5061DRUG

ITX 5061 (150mg) pre-transplant, immediately post-transplant and daily thereafter for 1 week.

ITX 5061

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years old, ≤ 65 years old
  • Plasma HCV RNA positive at time of listing for liver transplantation
  • Accepted for liver transplantation for any of:
  • End-stage liver disease due to HCV infection
  • End-stage liver disease due to HCV infection and alcohol related liver disease (ALD)
  • HCC due to HCV

You may not qualify if:

  • Refusal or inability to give informed consent
  • Viral co-infection with either hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Pregnancy or breastfeeding
  • Women, of child-bearing potential, who are not willing to practice effective contraception
  • Men, sexually active with women of child-bearing potential, who are not willing to practice effective contraception
  • Any situation that in the Investigator's opinion may interfere with optimal study participation
  • Participation in any clinical study of an investigational agent within 30 days of recruitment
  • Transplantation with a donor organ from a HCV positive individual

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Birmingham

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

Related Publications (2)

  • Syder AJ, Lee H, Zeisel MB, Grove J, Soulier E, Macdonald J, Chow S, Chang J, Baumert TF, McKeating JA, McKelvy J, Wong-Staal F. Small molecule scavenger receptor BI antagonists are potent HCV entry inhibitors. J Hepatol. 2011 Jan;54(1):48-55. doi: 10.1016/j.jhep.2010.06.024. Epub 2010 Aug 21.

    PMID: 20932595BACKGROUND

  • Rowe IA, Tully DC, Armstrong MJ, Parker R, Guo K, Barton D, Morse GD, Venuto CS, Ogilvie CB, Hedegaard DL, McKelvy JF, Wong-Staal F, Allen TM, Balfe P, McKeating JA, Mutimer DJ. Effect of scavenger receptor class B type I antagonist ITX5061 in patients with hepatitis C virus infection undergoing liver transplantation. Liver Transpl. 2016 Mar;22(3):287-97. doi: 10.1002/lt.24349.

    PMID: 26437376RESULT

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • David J Mutimer, FRCP

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2011

First Posted

February 10, 2011

Study Start

February 1, 2011

Primary Completion

January 1, 2013

Study Completion

May 1, 2013

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

GB(1)