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 @ 7:14 PM
Ignite Modification Date:
2025-12-24 @ 7:14 PM
NCT ID:
NCT01685203
Eligibility Criteria:
Inclusion Criteria:
* Females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile
* Subjects must meet one of the following:
* Treatment-naive: Subject has never received antiviral treatment for hepatitis C infection OR
* Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegIFN/RBV);
* Body mass index (BMI) is ≥ 18 to \< 38 kg/m\^2.
* Chronic HCV genotype 1b infection/with or without cirrhosis or HCV genotype 4 infection/without cirrhosis for at least 6 months prior to study screening.
* Subject has plasma HCV RNA level \> 10,000 IU/mL at Screening
Exclusion Criteria:
* History of severe, life-threatening or other significant sensitivity to any drug.
* Females who were pregnant or planned to become pregnant, or breastfeeding, or GT4-infected males whose partners were pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug/RBV.
* Recent history of drug or alcohol abuse that could preclude adherence to the protocol.
* Positive test result for hepatitis B surface antigen or anti-Human Immunodeficiency Virus (HIV) antibodies.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01685203
Study Brief:
Protocol Section:
NCT01685203