This trial is active, not recruiting.

Condition hepatitis c infection
Treatment itx 5061
Phase phase 1
Sponsor Schiano, Thomas D., MD
Collaborator iTherX Pharma, Inc.
Start date March 2012
End date May 2015
Trial size 10 participants
Trial identifier NCT01560468, 12-0123, HSM 12-00045


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
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.
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.

Primary Outcomes

Incidence of HCV recurrence post-transplant
time frame: 28 days

Secondary Outcomes

Change in serum HCV RNA
time frame: 3 months after transplant
Levels of ITX 5061
time frame: 28 days
Viral dynamics of serum HCV RNA
time frame: 24 hours post-transplant
Potential changes in plasma HCV E2
time frame: 28 days

Eligibility Criteria

Male or female participants from 18 years up to 72 years old.

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

Additional Information

Official title Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection
Principal investigator Thomas D Schiano, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Schiano, Thomas D., MD.