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 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT01687257
Eligibility Criteria:
Inclusion Criteria:
* Chronic infection with Hepatitis C with HCV RNA \> 1000 IU/mL
* Individuals with cirrhosis with Child-Pugh score \< 10
* Esophageal or gastric varices on endoscopy within 6 months prior to or at screening
* Hepatic Venous Pressure Gradient (HVPG) \> 6 mmHg
* Body mass index (BMI) ≥ 18 kg/m\^2
* Naïve to all nucleotides/nucleoside treatments for chronic HCV infection
Exclusion Criteria:
* Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance
* HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive)
* Alpha-fetoprotein (AFP) \> 50 unless negative imaging for hepatic masses within the last 6 months or during screening
* Refractory ascites as defined by requiring paracentesis \> twice within 1 month prior to screening
* Active variceal bleeding within 6 months of screening
* Expected survival of \< 1 year
* History of hepatorenal, or hepatopulmonary syndrome.
* Evidence of renal impairment (CrCl \< 50 mL/min)
* History of major organ transplantation, including liver transplant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01687257
Study Brief:
Protocol Section:
NCT01687257