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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT01591460
Eligibility Criteria:
Inclusion Criteria:
* Adult patients \>/=18 years of age
* Chronic liver disease consistent with chronic hepatitis C, genotype 1 infection
* Serum HCV RNA quantifiable at screening
* Patients who have not been previously treated with pegylated interferon (IFN), standard IFN, RBV or any direct acting anti-viral agent
* Compensated liver disease (Child-Pugh Grade A clinical classification for patients with cirrhosis: total score \</=6)
* Negative urine or blood pregnancy test (for women of childbearing potential)
Exclusion Criteria:
* Women with ongoing pregnancy or breast feeding
* Male partners of women who are pregnant
* Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment \</=6 months prior to the first dose of study drug
* Any investigational drug \</=6 weeks prior to the first dose of study drug
* History or other evidence of decompensated liver disease
* History or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C
* Signs or symptoms of hepatocellular carcinoma
* Co-infection with HCV genotypes other than genotype 1
* Co-infection with hepatitis A, hepatitis B, and/or human immunodeficiency virus (HIV)
* Any patient with an increased risk for anemia
* History of severe psychiatric disease
* History of immunologically mediated, chronic pulmonary, or severe cardiac disease
* Current diseases that are not adequately controlled
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01591460
Study Brief:
Protocol Section:
NCT01591460