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Study of Hepatitis C Virus (HCV) Entry Inhibitor in Liver Transplant Recipients With HCV Infection

Primary Purpose

Hepatitis C Infection

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ITX 5061

About this trial

This is an interventional prevention trial for Hepatitis C Infection focused on measuring Hepatitis C Virus Infection, Liver Transplantation

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Mount Sinai School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ITX 5061

Arm Description

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.

Outcomes

Primary Outcome Measures

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%).

Secondary Outcome Measures

Change in serum HCV RNA

To determine the change in serum HCV RNA from study entry to end of dosing (28 days) and 3 month follow up

Levels of ITX 5061

To assess trough levels of plasma ITX 5061 throughout the dosing period

Viral dynamics of serum HCV RNA

To characterize the viral dynamics of serum HCV RNA levels during the first 24 hours post-transplant

Potential changes in plasma HCV E2

To characterize potential changes in plasma HCV E2 (HCV envelope protein) regions in the setting of ITX 5061 administration

Full Information

NCT ID

NCT01560468

First Posted

February 15, 2012

Last Updated

April 16, 2018

Sponsor

Schiano, Thomas D., MD

Collaborators

iTherX Pharmaceuticals Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01560468

Brief Title

Study of Hepatitis C Virus (HCV) Entry Inhibitor in Liver Transplant Recipients With HCV Infection

Official Title

Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Terminated

Why Stopped

Financial Reasons

Study Start Date

March 2012 (undefined)

Primary Completion Date

April 2018 (Actual)

Study Completion Date

April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Schiano, Thomas D., MD

Collaborators

iTherX Pharmaceuticals Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

All subjects will receive 28 days of ITX 5061 beginning at the time of transplant. Dosing of ITX 5061 is as follows: Day of Transplant prior to surgery: ITX 5061 300 mg Day of Transplant following surgery: ITX 5061 300 mg Post-Operative Days 1-6: ITX 5061 300 mg Post-Operative Days 7-27: ITX 5061 150 mg Subjects will be monitored for HCV RNA levels, HDL cholesterol and ITX 5061 drug concentration levels. A liver biopsy will be performed at 6 months post-transplant to assess for histological signs of HCV recurrence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C Infection

Keywords

Hepatitis C Virus Infection, Liver Transplantation

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ITX 5061

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

ITX 5061

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of HCV recurrence post-transplant

Description

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Change in serum HCV RNA

Description

To determine the change in serum HCV RNA from study entry to end of dosing (28 days) and 3 month follow up

Time Frame

3 months after transplant

Title

Levels of ITX 5061

Description

To assess trough levels of plasma ITX 5061 throughout the dosing period

Time Frame

28 days

Title

Viral dynamics of serum HCV RNA

Description

To characterize the viral dynamics of serum HCV RNA levels during the first 24 hours post-transplant

Time Frame

24 hours post-transplant

Title

Potential changes in plasma HCV E2

Description

To characterize potential changes in plasma HCV E2 (HCV envelope protein) regions in the setting of ITX 5061 administration

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

72 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas D Schiano, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Sinai School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24041792

Citation

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.

Results Reference

derived

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Study of Hepatitis C Virus (HCV) Entry Inhibitor in Liver Transplant Recipients With HCV Infection

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