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 @ 1:53 PM
Ignite Modification Date:
2025-12-24 @ 1:53 PM
NCT ID:
NCT02636595
Eligibility Criteria:
Inclusion Criteria:
1. Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.
2. Chronic HCV infection.
3. HCV treatment-naïve or treatment experienced (interferon \[IFN\] or pegylated interferon \[pegIFN\] with or without ribavirin \[RBV\]; sofosbuvir \[SOF\] plus RBV with or without pegIFN).
4. Non-cirrhotic participants.
Exclusion Criteria:
1. History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs.
2. Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
5. Co-infection with more than one HCV genotype.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02636595
Study Brief:
Protocol Section:
NCT02636595