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 @ 11:50 AM
Ignite Modification Date:
2025-12-24 @ 11:50 AM
NCT ID:
NCT02378961
Eligibility Criteria:
Key Inclusion Criteria:
* Individuals with chronic HCV infection
* HCV RNA ≥10\^4 IU/mL at screening
* HCV genotypes 2, 3, 4, 5, or 6
* Cirrhosis determination; a liver biopsy may be required
* Screening laboratory values within defined thresholds
* Use of two contraception methods if female of childbearing potential or sexually active male
Key Exclusion Criteria:
* Pregnant or nursing female
* Current or prior history of hepatic decompensation
* Hepatocellular carcinoma (HCC) or other clinically significant malignancy
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02378961
Study Brief:
Protocol Section:
NCT02378961