Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-24 @ 5:59 PM
NCT ID:
NCT01560468
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.
Study:
NCT01560468
Study Brief:
Protocol Section:
NCT01560468