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 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT01193361
Eligibility Criteria:
Inclusion Criteria:
* Subjects chronically infected with HCV genotype 1 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to Screening, and positive for HCV RNA and anti-HCV antibody at Screening
* HCV RNA ≥ 10\*5\* IU/mL at Screening
* Less than 4 weeks total prior therapy with an IFN formulation (ie, IFNα, pegIFNα-2a), or RBV and no exposure to IFN or RBV within 24 weeks of Randomization
* Results of a biopsy obtained ≤ 24 months prior to Randomization showing no evidence of cirrhosis
* Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/ \[height (m)\]² at Screening
Exclusion Criteria:
* Liver transplant recipients
* Documented or suspected HCC by imaging or liver biopsy
* Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
* History of chronic hepatitis B virus (HBV) as documented by HBV serologies (eg. HBsAg-seropositive). Patients with resolved HBV infection may participate (eg. HBsAb-seropositive)
* Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01193361
Study Brief:
Protocol Section:
NCT01193361