NCT01560468

Brief Summary

This study will test the safety and tolerability of HCV Entry Inhibitor ITX 5061 in Liver Transplant Recipients with Hepatitis C infection. The investigators hypothesize that ITX 5061 oral monotherapy will be safe in adults during and after liver transplantation and that therapy will also inhibit HCV infection of newly transplanted livers in adults with prior HCV infection.

Trial Health

57
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Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

February 15, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

6.1 years

First QC Date

February 15, 2012

Last Update Submit

April 16, 2018

Conditions

Hepatitis C Infection

Keywords

Hepatitis C Virus InfectionLiver Transplantation

Outcome Measures

Primary Outcomes (1)

  • Incidence of HCV recurrence post-transplant

    We hypothesize that ITX 5061 oral monotherapy will be safe in adults during and after liver transplantation and will inhibit HCV infection of newly transplanted livers in adults with prior HCV infection. The number of treated subjects who are infected at 28 days post-transplant will be compared to the historical control rate (95%).

    28 days

Secondary Outcomes (4)

  • Change in serum HCV RNA

    3 months after transplant

  • Levels of ITX 5061

    28 days

  • Viral dynamics of serum HCV RNA

    24 hours post-transplant

  • Potential changes in plasma HCV E2

    28 days

Study Arms (1)

ITX 5061

EXPERIMENTAL

Subjects will receive ITX 5061 for 28 days beginning at the time of liver transplantation for hepatitis C virus. 300mg will be administered on the day of surgery and for one week post transplant, followed by 150mg for an additional 21 days.

Drug: ITX 5061

Interventions

ITX 5061DRUG

300 mg given orally beginning at the time of liver transplantation and for 1 week post-transplant followed by 150 mg orally for an additional 21 days.

ITX 5061

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-72
  • Patients accepted onto waiting list for liver transplantation for HCV related liver disease and receiving a deceased donor liver allograft
  • HCV RNA (+) at time of listing for transplantation. All HCV genotypes will be eligible
  • Patients with HCC and those receiving hepatitis B core (+) donor livers will be eligible
  • Standard immunosuppression protocol with tacrolimus, corticosteroid taper, and mycophenolate mofetil

You may not qualify if:

  • Viral co-infection (HBV/HIV)
  • Receipt of a HCV (+) donor allograft
  • Patients undergoing retransplantation for recurrent HCV
  • Multivisceral transplantation
  • Patients receiving anti-viral therapy at the time of LT
  • Live donor liver transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (1)

  • Sulkowski MS, Kang M, Matining R, Wyles D, Johnson VA, Morse GD, Amorosa V, Bhattacharya D, Coughlin K, Wong-Staal F, Glesby MJ; AIDS Clinical Trials Group A5277 Protocol Team. Safety and antiviral activity of the HCV entry inhibitor ITX5061 in treatment-naive HCV-infected adults: a randomized, double-blind, phase 1b study. J Infect Dis. 2014 Mar 1;209(5):658-67. doi: 10.1093/infdis/jit503. Epub 2013 Sep 16.

    PMID: 24041792DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

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

Study Officials

  • Thomas D Schiano, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2012

First Posted

March 22, 2012

Study Start

March 1, 2012

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

US(1)