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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT00696904
Eligibility Criteria:
Inclusion Criteria:
* Main Selection Criteria for Healthy Volunteers:
* Subject has provided written consent.
* Subject is in general good health.
* If female, subject is postmenopausal.
* If female, subject is not pregnant and is not breast-feeding.
* Main Selection Criteria for HCV+ Subjects:
* Subject is HAV-IgM, HBsAg or HIV Ab negative.
* Subject is HCV genotype 1 with HCV RNA of \> 50,000 IU/mL.
* Subject is excluded if they have previously received antiviral therapy for HCV infection
* Subjects must demonstrate chronic hepatitis C infection for at least 6 months prior to study enrollment
* Subjects must have a prior liver biopsy with histology consistent with HCV induced liver damage, and with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV.
Exclusion Criteria:
See above for main selection criteria
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00696904
Study Brief:
Protocol Section:
NCT00696904