Trial | NCT01560468  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    itx 5061 ...

  • Study Participants

    10
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.
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 Started
Mar 31
2012
Primary Completion
Apr 30
2018
Study Completion
Apr 30
2018
Last Update
Apr 18
2018

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.

ITX 5061 Experimental

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.

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
No Results Posted