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 @ 10:15 PM
Ignite Modification Date:
2025-12-24 @ 10:15 PM
NCT ID:
NCT01582035
Eligibility Criteria:
Inclusion Criteria:
* genotype 1a or 1b HCV infection with HCV RNA level \> 100,000 IU/mL
* A documented prior relapser patient to previous treatment regimens or treatment-naïve
* Patient must have documentation of a liver biopsy within 3 years before the screening visit or must agree to have a fibroscan/elastography examination within the screening period
* Patient is judged to be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
Exclusion Criteria:
* Evidence of liver cirrhosis
* Evidence of decompensated liver disease
* Evidence of any other cause of significant liver disease in addition to hepatitis C
* receiving or having received any treatment for HCV during the 6 months before screening
* History or evidence of current abuse of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise subject's safety and/or compliance with the study procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01582035
Study Brief:
Protocol Section:
NCT01582035