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 @ 12:44 PM
Ignite Modification Date:
2025-12-24 @ 12:44 PM
NCT ID:
NCT01314261
Eligibility Criteria:
Inclusion Criteria:
* Treatment naïve participants
* Females must be either postmenopausal for at least 2 years or surgically sterile
* Males must be surgically sterile or practicing specific forms of birth control
* Chronic hepatitis C virus (HCV), genotype-1 infected participants
* Documented FibroTest score in combination with an Aspartate Aminotransferase to Platelet Ratio Index (APRI), or a liver biopsy within the last 12 months to document absence of cirrhosis
Exclusion Criteria:
* Pregnant or breastfeeding female
* Use of any medications contraindicated for use with pegylated interferon(pegIFN) or ribavirin (RBV) 2 weeks prior to study drug administration or 10 half-lives, whichever is longer
* Clinically significant cardiac, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic disease, or any uncontrolled medical illness or psychiatric disease or disorder
* Current or past clinical evidence of cirrhosis or bridging fibrosis
* Abnormal screening laboratory results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01314261
Study Brief:
Protocol Section:
NCT01314261