Hepatitis C Infection
Conditions
Keywords
Hepatitis C Virus Infection, Liver Transplantation
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.
Interventions
DRUGITX 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.
Sponsors
iTherX Pharmaceuticals Inc.
Schiano, Thomas D., MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of HCV recurrence post-transplant | 28 days | We hypothesize that ITX 5061 oral monotherapy will be safe in adults during and after liver transplantation and will inhibit HCV infection of newly transplanted livers in adults with prior HCV infection. The number of treated subjects who are infected at 28 days post-transplant will be compared to the historical control rate (95%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum HCV RNA | 3 months after transplant | To determine the change in serum HCV RNA from study entry to end of dosing (28 days) and 3 month follow up |
| Levels of ITX 5061 | 28 days | To assess trough levels of plasma ITX 5061 throughout the dosing period |
| Viral dynamics of serum HCV RNA | 24 hours post-transplant | To characterize the viral dynamics of serum HCV RNA levels during the first 24 hours post-transplant |
| Potential changes in plasma HCV E2 | 28 days | To characterize potential changes in plasma HCV E2 (HCV envelope protein) regions in the setting of ITX 5061 administration |
Countries
United States
Outcome results
None listed