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

Phase 1

Terminated

• Conditions: Hepatitis C Infection
• Interventions: Drug: ITX 5061

• Registration Number: NCT01560468
• Lead Sponsor: Schiano, Thomas D., MD

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.

Study Timeline

• Study First Submitted: 2012-02-15
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-22
• Status Verified: 2018-04
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ITX 5061	ITX 5061	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.

Primary Outcome Measures

Name	Time	Method
Incidence of HCV recurrence post-transplant	28 days	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

Name	Time	Method
Viral dynamics of serum HCV RNA	24 hours post-transplant	To characterize the viral dynamics of serum HCV RNA levels during the first 24 hours post-transplant
Change in serum HCV RNA	3 months after transplant	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	28 days	To assess trough levels of plasma ITX 5061 throughout the dosing period
Potential changes in plasma HCV E2	28 days	To characterize potential changes in plasma HCV E2 (HCV envelope protein) regions in the setting of ITX 5061 administration

Trial Locations

Locations (1)

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States