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 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT01547312
Eligibility Criteria:
Inclusion Criteria:
* Has chronic compensated HCV infection.
* No contraindications to CNB or FNA procedures.
* Pilot study only: All comers with chronic HCV already scheduled to undergo CNB for fibrosis staging.
* Pilot study only: Requires a diagnostic liver biopsy to monitor progression of liver disease.
* Pilot study only: Does not have cirrhosis.
* Main study only: Males or non-pregnant and postmenopausal females willing to use medically acceptable contraception during, and for 6 months or longer after study.
* Main study only: Body mass index of 18.5 - 32.0 kg/m\^2.
* Main study only: Can avoid aspirin, anticoagulants, and non steroidal inflammatory agents.
* Main study only: Has undergone prior treatment or is treatment naive for chronic HCV infection.
Exclusion Criteria for Main study only:
* History of any of the following: stroke, chronic seizures, major neurological disorders, gastric bypass surgery or bowel resection.
* No viral response to prior interferon based therapy.
* Prior treatment for HCV with an NS3/4A protease inhibitor.
* History of either clinically significant, uncontrolled endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities/diseases.
* History of neoplastic or myeloproliferative disease.
* Has any of the following : cirrhosis, decompensated liver disease, or other advanced liver disease, hepatocellular carcinoma, infection with human immunodeficiency virus (HIV), or hepatitis B.
* Evidence of high grade bridging fibrosis from prior liver biopsy or chronic hepatitis not caused by HCV.
* History of illicit drug use or alcohol abuse.
* Had surgery, donated at least one unit of blood, or participated in any other investigational study within 4 weeks prior to screening visit.
* History of multiple and/or severe allergies.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01547312
Study Brief:
Protocol Section:
NCT01547312