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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT02392494
Eligibility Criteria:
Inclusion Criteria:
* Male or female of non-child bearing potential
* In good health other than HCV genotype (GT) 1 infection
Exclusion Criteria:
* Is mentally incapacitated or legally institutionalized
* Has a history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting HCV infection), immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer
* Is positive for hepatitis B surface antigen (HBsAg) or human immunodeficiency virus (HIV)
* Has participated in another investigational trial within 4 weeks (or 5 half-lives) prior to Screening
* Consumes \>2 alcoholic beverages a day or uses illegal drugs
* Has evidence or history of chronic hepatitis not caused by HCV including but not limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug-induced hepatitis, or autoimmune hepatitis
* Has clinical or laboratory evidence of advanced or decompensated liver disease, evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3) from prior liver biopsy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02392494
Study Brief:
Protocol Section:
NCT02392494