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

Schiano, Thomas D., MD

Status and phase: Terminated; Phase 1

Conditions: Hepatitis C Infection

Treatments: Drug: ITX 5061

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01560468

12-0123 (Other Identifier)

HSM 12-00045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

ITX 5061

Experimental group

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.

Treatment:

Drug: ITX 5061