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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT01573351
Eligibility Criteria:
Inclusion Criteria:
* Males and females, ≥ 18 years of age
* HCV Genotype 1 or 4 who previously failed treatment with Peginterferon alfa-2a or peginterferon alfa-2b and Ribavirin (P/R), classified as previous null and partial responders based on previous therapy
* HCV RNA ≥ 10,000 IU/mL
* Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)
* Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)
Exclusion Criteria:
* Prior treatment of HCV with HCV direct acting antiviral (DAA)
* Evidence of a medical condition contributing to chronic liver disease other than HCV
* Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
* Diagnosed or suspected hepatocellular carcinoma or other malignancies
* Uncontrolled diabetes or hypertension
* Total bilirubin ≥ 34 μmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease
* Alanine aminotransferase (ALT) ≥ 5x Upper limit of normal (ULN)
* Albumin \< 3.5 g/dL (35 g/L)
* Alpha Fetoprotein (AFP) \> 100 ng/mL (\>82.6 IU/mL) or ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of Hepatocellular carcinoma (HCC) are excluded
* Absolute neutrophil count (ANC) \< 1.5 x 1000,000,000 cells/L (\< 1.2 x 1000,000,000 cells/L for Black/African-Americans)
* Platelets \< 90 x 1000,000,000 cells/L
* Hemoglobin \< 12 g/dL for females or \< 13 g/dL for males
* Any criteria that would exclude the subject from receiving P/R
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01573351
Study Brief:
Protocol Section:
NCT01573351