NCT01560468

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Schiano, Thomas D., MD · Academic / Other
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2012-03-22
• Last updated: 2018-04-18

Locations

1 site across 1 country: United States