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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT01896193
Eligibility Criteria:
Inclusion Criteria:
* Confirmed chronic genotype 1 or 3 HCV infection
* HCV treatment-naive
* Individuals will have cirrhosis status assessment; liver biopsy may be required.
* Screening laboratory values within predefined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria:
* Pregnant or nursing female or male with pregnant female partner
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Contraindication to ribavirin therapy
* Excessive alcohol ingestion as defined by protocol
* History of solid organ transplantation
* Current or prior history of clinical hepatic decompensation
* History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01896193
Study Brief:
Protocol Section:
NCT01896193