Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-26 @ 12:33 AM
Study NCT ID:
NCT01560468
Status:
TERMINATED
Last Update Posted:
2018-04-18
First Post:
2012-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Hepatitis C Virus (HCV) Entry Inhibitor in Liver Transplant Recipients With HCV Infection
Sponsor:
Schiano, Thomas D., MD
Organization:
Study Overview
Official Title:
Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection
Status:
TERMINATED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Financial Reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 12-0123 | OTHER | Mount Sinai GCO | View |