Clinical trial NCT01560468: Study of Hepatitis C Virus (HCV) Entry Inhibitor in Liver Transplant Recipients With HCV Infection
Official title: Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hepatitis C Infection
Keywords: Hepatitis C Virus Infection
Liver Transplantation
Lead sponsor: Schiano, Thomas D., MD
Sponsor class: OTHER
Collaborators: name: iTherX Pharmaceuticals Inc.
First posted: 2012-03-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Incidence of HCV recurrence post-transplant
timeFrame: 28 days
Secondary outcomes:
measure: Change in serum HCV RNA
timeFrame: 3 months after transplant
measure: Levels of ITX 5061
timeFrame: 28 days
measure: Viral dynamics of serum HCV RNA
timeFrame: 24 hours post-transplant
measure: Potential changes in plasma HCV E2
timeFrame: 28 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Thomas D Schiano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sulkowski MS, Kang M, Matining R, Wyles D, Johnson VA, Morse GD, Amorosa V, Bhattacharya D, Coughlin K, Wong-Staal F, Glesby MJ; AIDS Clinical Trials Group A5277 Protocol Team. Safety and antiviral activity of the HCV entry inhibitor ITX5061 in treatment-naive HCV-infected adults: a randomized, double-blind, phase 1b study. J Infect Dis. 2014 Mar 1;209(5):658-67. doi: 10.1093/infdis/jit503. Epub 2013 Sep 16.