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 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT04048850
Eligibility Criteria:
Inclusion Criteria:
* Adults (at least 18 years of age or older)
* Chronic HCV (HCV antibody positive with detectable HCV-RNA)
* HCV genotypes 1a, without the presence of baseline NS5A resistance (specifically, polymorphisms at amino acid positions 28, 30, 31, or 93), 1b, or 4
* HCV treatment-naïve or peginterferon/ribavirin-experienced
* Managed by the UI Health Infectious Diseases Clinic or Liver Clinic
* Recent or current substance use (per self-report or electronic medical record (EMR) data within 90 days of the screening visit, with or without positive baseline urine toxicology), inclusive of one or more of the following: Opiate substitution therapy; Prescription medication misuse (including: opiates, sedatives, tranquilizers, hypnotics, and psychostimulants); Illicit substances; Injection drug use; Alcohol
Exclusion Criteria:
* Incarcerated
* Pregnant or breastfeeding
* Decompensated liver disease (Child-Pugh B or C)
* Albumin below 3 g/dL
* Platelet count below 75,000
* Unwilling to commit to treatment and/or monitoring
* Poor venous access inhibiting laboratory collection
* Any condition considered by the investigators to be a contraindication to study participation
* Hepatitis B virus (HBV) surface antigen (HBsAg) positive
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04048850
Study Brief:
Protocol Section:
NCT04048850