Study of Hepatitis C Virus (HCV) Entry Inhibitor in Liver Transplant Recipients With HCV Infection
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection|
- Incidence of HCV recurrence post-transplant [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]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%).
- Change in serum HCV RNA [ Time Frame: 3 months after transplant ] [ Designated as safety issue: No ]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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]To assess trough levels of plasma ITX 5061 throughout the dosing period
- Viral dynamics of serum HCV RNA [ Time Frame: 24 hours post-transplant ] [ Designated as safety issue: No ]To characterize the viral dynamics of serum HCV RNA levels during the first 24 hours post-transplant
- Potential changes in plasma HCV E2 [ Time Frame: 28 days ] [ Designated as safety issue: No ]To characterize potential changes in plasma HCV E2 (HCV envelope protein) regions in the setting of ITX 5061 administration
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: ITX 5061
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560468
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Thomas D Schiano, MD||Mount Sinai School of Medicine|