Study of Hepatitis C Virus (HCV) Entry Inhibitor in Liver Transplant Recipients With HCV Infection

NCT ID: NCT01560468

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2018-04-30

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.

Conditions

Hepatitis C Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ITX 5061

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

iTherX Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: collaborator

Schiano, Thomas D., MD

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas D Schiano, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai School of Medicine

New York, New York, United States

Countries

United States

References

Sulkowski MS, Kang M, Matining R, Wyles D, Johnson VA, Morse GD, Amorosa V, Bhattacharya D, Coughlin K, Wong-Staal F, Glesby MJ; AIDS Clinical Trials Group A5277 Protocol Team. Safety and antiviral activity of the HCV entry inhibitor ITX5061 in treatment-naive HCV-infected adults: a randomized, double-blind, phase 1b study. J Infect Dis. 2014 Mar 1;209(5):658-67. doi: 10.1093/infdis/jit503. Epub 2013 Sep 16.

Reference Type: DERIVED

PMID: 24041792 (View on PubMed)

Other Identifiers

12-0123

Identifier Type: OTHER

Identifier Source: secondary_id

HSM 12-00045

Identifier Type: -

Identifier Source: org_study_id