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:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-25 @ 4:24 AM
NCT ID:
NCT03650920
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* Age 18 and older
* Active on the transplant list
* Donor organ with Antibody and nucleic acid test (NAT) positive for HCV
* Graft with F2 fibrosis or less at time of explant
* HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
* Willing and able to provide written informed consent or for those subjects where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative willing and able to provide consent on behalf of the subject
Exclusion Criteria:
* Participants co-infected with HIV
* Donor previously treated with a non-structural protein 5A (NS5a) containing regimen (if treatment history of donor known)
* Known allergies or hypersensitivity to direct acting antiviral drug (DAA) or ribavirin (RBV)
* Pregnancy and/or actively breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03650920
Study Brief:
Protocol Section:
NCT03650920