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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT01651767
Eligibility Criteria:
Inclusion Criteria:
* Chronic (diagnosis of hepatitis C more than or 6 months before the screening period) HCV infection. Geno- and subtype should be determined or confirmed at screening, and should be 1a or 1b
* Never received (Peg) IFN, RBV or any other approved or investigational antiviral treatment for chronic HCV infection
* HCV RNA level of \>100,000 IU/mL at screening (as assessed by standard quantitative in vitro nucleic acid amplification assay)
* Patients having good accessible veins
Exclusion Criteria:
* Evidence of liver cirrhosis or decompensated liver disease
* Patient coinfected with HIV-1 or HIV-2, or hepatitis A or B virus infection, or active tuberculosis at study screening
* Patient infected/coinfected with non-genotype-1 HCV at study screening
* Patient with any cardiac disease at screening, or any active clinically significant disease, or medical history or physical examination findings during screening
* Patient having uncontrolled/unstable disease such as diabetes, epilepsy, a manifest psychiatric disease, thyroid disease or disorders
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01651767
Study Brief:
Protocol Section:
NCT01651767