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

• Status: Terminated
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

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