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:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT01750216
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, \>/= 18 years of age
* Chronic hepatitis C genotype 1
* Treatment-naïve, i.e. have not been previously treated with pegylated interferon, standard interferon and ribavirin
* Confirmed serum positive HCV RNA
* Liver fibrosis confirmed histologically or by fibroscan up to 24 months before treatment
Exclusion Criteria:
* Any contraindications according to the Summary of Product Characteristics for Pegasys or Copegus
* Co-infection with hepatitis B or HIV
* Post-transplant patients
* End stage renal disease (creatinine clearance \< 15 ml/min)
* Patients treated with immunotherapy
* Pregnant women and male partners of women who are pregnant
* Female patients of childbearing potential and male patients with female partners of childbearing potential who are unable or unwilling to use effective and continuous contraception during the treatment and for 4 months (females) and 7 months (males) thereafter
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01750216
Study Brief:
Protocol Section:
NCT01750216