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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT02865369
Eligibility Criteria:
Inclusion Criteria:
* Chronically infected with Hepatitis C virus genotype 1b
* HCV RNA ≥ 10\^4 IU/mL (10,000 IU/mL)
* Chronic Hepatitis C with advanced fibrosis or cirrhosis (defined as ≥F3, ≥8 kilopascals)
* Treatment-naïve or those who previously failed to treatment with peg-interferon alfa and ribavirin
* Women of childbearing potential (WOCBP) and men, who use effective methods of birth control
Exclusion Criteria:
* Patients with baseline key NS5A RAVs (Y93 and/or L31)
* Estimated GFR \< 30mL/min without hemodialysis
* Alanine aminotransferase (ALT) \> 100 IU/L
* Coinfection with other hepatitis virus or human immunodeficiency virus
* A daily alcohol intake \>30 g
* Decompensated liver disease or hepatocellular carcinoma, liver or any other organ transplantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02865369
Study Brief:
Protocol Section:
NCT02865369