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 @ 11:46 PM
Ignite Modification Date:
2025-12-24 @ 11:46 PM
NCT ID:
NCT00160251
Eligibility Criteria:
Key inclusion criteria:
* Documented infection with chronic hepatitis C (CHC), genotype 1.
* Documented failure to respond to an adequate course of treatment (minimum 12 weeks) with peginterferon-alfa plus ribavirin (failure defined as \<2 log drop in HCV-RNA after 12 weeks of therapy or those who never become Hepatitis C Virus Ribonucleic Acid (HCV)-RNA negative)
* No evidence of cirrhosis on liver biopsy.
* Results of physical examination and laboratory tests within specified ranges.
* Abstinence from use of abused substances.
Key exclusion criteria:
* Women who are pregnant or nursing a child.
* Patients with cirrhosis, co-infection with Hepatitis B or human immunodeficiency virus (HIV), and African-American patients (by protocol amendment 2, African-American patients can enroll).
* Previous treatment with any Hepatitis C Virus (HCV) polymerase or protease inhibitor.
* Patients who relapsed following response to previous treatment.
* Evidence of advanced liver disease, or liver disease from a cause other than CHC.
* Pre-existing psychiatric condition.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00160251
Study Brief:
Protocol Section:
NCT00160251