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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT02745535
Eligibility Criteria:
Inclusion Criteria:
* Available for clinical follow-up through Week 44 after enrollment.
* Recurrent HCV GT-1
* Exposure to combination DAA therapy
* Able and willing to complete the informed consent process.
* Use of protocol specified methods of contraception
* Hepatitis B coinfected participants must have evidence of chronic infection and controlled on treatment
* HIV coinfected participants must have HIV status of one of the following:
1. HIV untreated for \>8 weeks prior to screening, CD4 \>500, no intention of initiating ARV therapy for the duration of the trial.
2. HIV suppressed on a stable, protocol-approved ARV regimen for \>4 weeks prior to screening.
Exclusion Criteria:
* Combination DAA therapy was completed or discontinued less than 8 weeks prior to enrollment.
* Current or prior history of any clinically significant illness, organ transplantation, and/or concomitant medication that may interfere with the subject treatment, assessment of compliance with the protocol.
* Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
* Laboratory results outside acceptable ranges at screening.
* Female who is pregnant, breast-feeding or planning to become pregnant during study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02745535
Study Brief:
Protocol Section:
NCT02745535