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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT01544920
Eligibility Criteria:
Inclusion Criteria:
* Is ≥ 40 kg and ≤ 125 kg.
* Documented CHC genotype 1 with HCV RNA ≥10,000 International Units (IU)/mL
* Has IL-28B CC allele gene
* Has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma (non-invasive fibroscan and Fibrotest can also be used for staging of liver disease).
Exclusion Criteria:
* Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen \[HBsAg\] or HIV positive).
* Previously treated with an interferon and ribavirin regimen or HCV direct acting antiviral regimen.
* Treatment for hepatitis C with any investigational medication, or prior treatments with herbal remedies with known hepatotoxicity
* Receiving any medication(s) within 2 weeks prior to the Day 1 visit that are highly dependent on Cytochrome P450 3A4 (CYP3A4/5) for clearance, and for which elevated plasma concentrations could be associated with serious and/or life-threatening events
* Participation in any other clinical trial within 30 days of the screening visit in this trial or intention to participate in another clinical trial during participation in this trial.
* Evidence of decompensated liver disease or hepatocellular carcinoma (HCC)
* Is diabetic and/or hypertensive with significant retinopathy
* Has any known medical condition that could interfere with the participation in and completion of the trial including immunologically-mediated disease, chronic pulmonary disease, or current or history of any clinically significant cardiac abnormalities/dysfunction.
* Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
* Hemoglobin \<12 g/dL for females and \<13 g/dL for males
* Neutrophils \<1,500/mm\^3, or \<1,200/mm\^3 for participants of African descent
* Platelets \<150,000/mm\^3
* Direct bilirubin \>1.5 x upper limit of normal (ULN) of the laboratory reference range.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01544920
Study Brief:
Protocol Section:
NCT01544920