Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT02692703
Eligibility Criteria:
Inclusion Criteria:
* Male or female, at least 18 years of age at time of screening.
* Screening laboratory result indicating hepatitis C virus (HCV) genotype 1-6 (GT1-6) infection.
* Subject is a recipient of a cadaveric or living donor liver transplant which was a consequence of HCV infection at least 3 months prior to screening Or subject received a cadaveric or living donor kidney at least 3 months before screening.
* Subjects must be documented as non-cirrhotic.
* Subject is currently taking a stable immunosuppression regimen based on tacrolimus, sirolimus, everolimus, mycophenolate mofetil (MMF), mycophenolic acid, azathioprine, and/or cyclosporine.
Exclusion Criteria:
* Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
* Clinical history of fibrosing cholestatic hepatitis post-transplant.
* Re-transplantation of the liver or kidney.
* Steroid resistant rejection of the transplanted liver or kidney, or a history of rejection treated with high dose steroid within 3 months of screening.
* History of post-transplant complications related to hepatic or renal vasculature.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02692703
Study Brief:
Protocol Section:
NCT02692703