Pilot Study of Hepatitis C Virus Entry Inhibitor (ITX 5061) in Liver Transplant Recipients

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase I pilot study to determine the safety and preliminary efficacy of a novel hepatitis C virus (HCV) entry inhibitor (ITX 5061) in patients with HCV infection undergoing liver transplantation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Birmingham
• Collaborators: National Institute for Health Research, United Kingdom; University Hospital Birmingham
• Treatments: Liver Extracts

Criteria

Inclusion Criteria:

• Age ≥ 18 years old, ≤ 65 years old

• Plasma HCV RNA positive at time of listing for liver transplantation

• Accepted for liver transplantation for any of:

• End-stage liver disease due to HCV infection

• End-stage liver disease due to HCV infection and alcohol related liver disease (ALD)

• HCC due to HCV

Exclusion Criteria:

• Refusal or inability to give informed consent

• Viral co-infection with either hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

• Pregnancy or breastfeeding

• Women, of child-bearing potential, who are not willing to practice effective contraception

• Men, sexually active with women of child-bearing potential, who are not willing to practice effective contraception

• Any situation that in the Investigator's opinion may interfere with optimal study participation

• Participation in any clinical study of an investigational agent within 30 days of recruitment

• Transplantation with a donor organ from a HCV positive individual