Pilot Study of Hepatitis C Virus Entry Inhibitor (ITX 5061) in Liver Transplant Recipients (NCT01292824) | Clinical Trial Compass
CompletedPhase 1
Pilot Study of Hepatitis C Virus Entry Inhibitor (ITX 5061) in Liver Transplant Recipients
United Kingdom24 participantsStarted 2011-02
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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
What they're measuring
1
To determine the safety of ITX 5061 in liver transplant recipients