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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT00896233
Eligibility Criteria:
Inclusion Criteria:
* Male or female and at least 18 years of age
* Generally good health
* Willing to fast for 8 hours prior to each study visit
Hepatitis C Virus (HCV) Inclusion Criteria:
* Positive serology for HCV and detectable HCV ribonucleic acid (RNA) in blood within 12 weeks of screening;
For Part I, known fibrosis stage of at least =F2 (METAVIR) or =F3 (Ishak) from biopsy performed within 3 months of screening; For Part 2, known fibrosis stage of F1-F4 (METAVIR) or F1-F6 (Ishak)
* Never been treated for HCV
Healthy Participant Inclusion Criteria:
* Documented absence of hepatitis B virus, HCV, acute hepatitis A virus, and human immunodeficiency virus (HIV) within 12 weeks of screening
Exclusion Criteria:
* History of stroke, seizures, or neurological disorders
* Consumption of excessive amounts of alcohol
* Use of products containing nicotine
* Unable to hold a breath for 20 seconds
* Claustrophobia
* Use of illicit drugs or history of drug or alcohol abuse
HCV-Positive Exclusion Criteria:
* Evidence or history of chronic hepatitis not caused by HCV
* HIV
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00896233
Study Brief:
Protocol Section:
NCT00896233