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 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT01591668
Eligibility Criteria:
Inclusion Criteria:
* Males and Females 18-65 years old
* Chronic HCV infection for at least 6 months, treatment naive
* HCV Viral load \> 100,000 IU/mL at Screening
* Monoinfection with HCV 1 genotype
* Hepatitis B surface antigen negative
* Screening ECG without clinically significant abnormalities
* BMI 18-33 kg/m\^2
* Creatinine clearing \> 70 mL/min
* Negative pregnancy test at screening
Exclusion Criteria:
* Pregnant or lactating subjects
* Co-infection with hepatitis B virus (HBV) or HIV
* History of Gilberts disease
* Particular abnormal laboratory parameters
* Diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), malignancy, hemoglobinopathy, retinal disease, and those who are immunosuppressed
* Evidence of hepatocellular carcinoma
* On-going alcohol abuse
* Positive uring drug screen
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01591668
Study Brief:
Protocol Section:
NCT01591668