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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Schiano, Thomas D., MD
Sponsor:
Collaborator:
iTherX Pharma, Inc.
Information provided by (Responsible Party):
Schiano, Thomas D., MD
ClinicalTrials.gov Identifier:
NCT01560468
First received: February 15, 2012
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Hepatitis C Infection
Drug: ITX 5061
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection

Resource links provided by NLM:


Further study details as provided by Schiano, Thomas D., MD:

Primary Outcome Measures:
  • Incidence of HCV recurrence post-transplant [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    We hypothesize that ITX 5061 oral monotherapy will be safe in adults during and after liver transplantation and will inhibit HCV infection of newly transplanted livers in adults with prior HCV infection. The number of treated subjects who are infected at 28 days post-transplant will be compared to the historical control rate (95%).


Secondary Outcome Measures:
  • Change in serum HCV RNA [ Time Frame: 3 months after transplant ] [ Designated as safety issue: No ]
    To determine the change in serum HCV RNA from study entry to end of dosing (28 days) and 3 month follow up

  • Levels of ITX 5061 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    To assess trough levels of plasma ITX 5061 throughout the dosing period

  • Viral dynamics of serum HCV RNA [ Time Frame: 24 hours post-transplant ] [ Designated as safety issue: No ]
    To characterize the viral dynamics of serum HCV RNA levels during the first 24 hours post-transplant

  • Potential changes in plasma HCV E2 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    To characterize potential changes in plasma HCV E2 (HCV envelope protein) regions in the setting of ITX 5061 administration


Estimated Enrollment: 10
Study Start Date: March 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560468

Contacts
Contact: Thomas D Schiano, MD 212-659-8502 Thomas.Schiano@mountsinai.org
Contact: Brandy M Haydel, BS 212-241-0255 Brandy.Haydel@mountsinai.org

Locations
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Thomas D Schiano, MD    212-659-8502    Thomas.Schiano@mountsinai.org   
Contact: Brandy M Haydel, CCRC    212-241-0255    Brandy.Haydel@mountsinai.org   
Principal Investigator: Thomas D Schiano, MD         
Sub-Investigator: Sander S Florman, MD         
Sponsors and Collaborators
Schiano, Thomas D., MD
iTherX Pharma, Inc.
Investigators
Principal Investigator: Thomas D Schiano, MD Mount Sinai School of Medicine
  More Information

No publications provided by Schiano, Thomas D., MD

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Schiano, Thomas D., MD
ClinicalTrials.gov Identifier: NCT01560468     History of Changes
Other Study ID Numbers: HSM 12-00045, 12-0123
Study First Received: February 15, 2012
Last Updated: April 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Schiano, Thomas D., MD:
Hepatitis C Virus Infection
Liver Transplantation

Additional relevant MeSH terms:
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
Infection
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014