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 @ 2:03 PM
Ignite Modification Date:
2025-12-24 @ 2:03 PM
NCT ID:
NCT01012895
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects ages 18 to 70 years
* HCV-Infected Genotype 1 Null responders to current standard of care
* Expansion Cohorts A1 and A2 are restricted to patients infected with HCV Genotype 1b only.
Exclusion Criteria:
* Evidence of a medical condition associate with chronic liver disease other than HCV
* History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
* History of Cancer within 5 years of enrollment
* History of gastrointestinal disease or surgical procedure (except Cholecystectomy)
* History of clinically significant cardiac disease
* History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Documented cirrhosis within 12 months prior to dosing
* Positive for Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)
* Pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01012895
Study Brief:
Protocol Section:
NCT01012895