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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT01247194
Eligibility Criteria:
Eligibility Criteria:
* Male or female, between 18 and 65 years of age (female patients must be surgically sterile or 2 years post-menopausal and are required to take a pregnancy test)
* Body Mass Index (BMI) 18 - 32 kg/m2
* Chronically infected with hepatitis C genotype-1 virus
* Serum HCV RNA \> 5 log10 IU/mL
* No previous treatment with interferon, peginterferon, ribavirin or any investigational HCV antiviral agents
* No history of signs or symptoms of decompensated liver disease
* No known history of cirrhosis
* No co-infection with HBV, HIV-1, HIV-2
* No history of any medical condition that may interfere with absorption, distribution or elimination of study drug or with the clinical and laboratory assessments in this study
* No history of alcohol abuse, or illicit drug use within 2 years prior to Screen, or enrollment in a methadone maintenance program (unless he/she has been enrolled in the methadone program for at least 3 months with good compliance, stable psychosocial circumstances, and no known current risks for recidivism)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01247194
Study Brief:
Protocol Section:
NCT01247194