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 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT02021656
Eligibility Criteria:
Key Inclusion Criteria:
* Willing and able to provide written informed consent
* HCV RNA ≥ 10\^4 IU/mL at screening
* HCV treatment-naive, as defined as no prior exposure to any interferon (IFN) or other approved or experimental HCV-specific direct-acting antiviral agent; OR HCV treatment-experienced with medical records that include sufficient detail of prior IFN-based treatment to allow for categorization of prior response as either intolerant, non-responder, or experienced viral breakthrough or relapse.
* Genotype 1 HCV at screening
* HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy
Key Exclusion Criteria:
* Pregnant or nursing female
* Chronic liver disease of a non-HCV etiology
* Current or prior history of any clinically-significant illness (other than HCV)
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02021656
Study Brief:
Protocol Section:
NCT02021656