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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT03050905
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older
* Male and female
* HCV Genotype 2K/1B (P/R experienced or naïve; non-cirrhotic/ Comp. cirrhotic CP-A 5)
* Capable to provide informed consent
Exclusion Criteria:
* Could not remain in the study for 36 weeks
* Co-infected with human immunodeficiency virus (HIV) or HBV
* Severe renal impairment (calculated creatinine clearance \<30 mL/min )
* Evidence of hepatocellular carcinoma (HCC)
* Severe concurrent disease
* Pregnant, lactating, expecting to conceive or donate eggs or male participant with pregnant female partner
* DAA treatment experienced
* History of drug or alcohol abuse within 6 months prior enrolment - positive result of a urine drug screen at the screening visit and a positive result on the alcohol consumption questioner.
* Evidence or history of chronic liver disease not caused by HCV Participants currently enrolled in an HCV-related research protocol OR currently receiving HCV treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03050905
Study Brief:
Protocol Section:
NCT03050905