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

Stopped early · Phase 1

Conditions studied: Hepatitis C Infection

In brief

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.

Key facts

Study ID

NCT01560468

Run by

Schiano, Thomas D., MD

People needed

10

Starts

2012-03-01

Expected to finish

2018-04-01

Last updated by the study team

2018-04-18

Who can join

Age: 18 and older, up to 72. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mount Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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