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

Hepatitis C Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01560468
• Other study ID #: HSM 12-00045
• Secondary ID: 12-0123
• Status: Terminated
• Phase: Phase 1
• First received: February 15, 2012
• Last updated: April 16, 2018
• Start date: March 2012
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Schiano, Thomas D., MD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Infection
• Infection

Intervention

Drug:
• ITX 5061
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.

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Schiano, Thomas D., MD	iTherX Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	3 months after transplant
Secondary	Levels of ITX 5061	To assess trough levels of plasma ITX 5061 throughout the dosing period	28 days
Secondary	Viral dynamics of serum HCV RNA	To characterize the viral dynamics of serum HCV RNA levels during the first 24 hours post-transplant	24 hours post-transplant
Secondary	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	28 days