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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT01278134
Eligibility Criteria:
Inclusion Criteria:
* Adult patient, \>/= 18 years of age
* Chronic Hepatitis C of \>/= 6 months duration at screening
* HCV genotype 1 and quantifiable HCV RNA at screening (Roche COBAS TaqMan HCV test)
* Naïve for treatment with interferon (pegylated or non-pegylated)
* Body Mass Index (BMI) 18-35 inclusive, minimum weight 45 kg
* Females of child-bearing potential and males with female partners of childbearing potential must use 2 forms of effective non-hormonal contraception
Exclusion Criteria:
* Pregnant or lactating women and males with female partners who are pregnant or lactating
* Decompensated liver disease or impaired liver function
* Cirrhosis or incomplete/transition to cirrhosis
* Non-hepatitis C chronic liver disease
* Hepatitis B or HIV infection
* History of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin
* History of pre-existing renal disease (except for nephrolithiasis) or severe cardiac disease
* History of drug or alcohol abuse within the last year or alcohol consumption of \> 2 units per day; cannabinoid use is excepted
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01278134
Study Brief:
Protocol Section:
NCT01278134