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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT02806505
Eligibility Criteria:
Inclusion Criteria:
* Serum hepatitis C virus ribonucleic acid (HCV RNA) quantifiable at greater than (\>) 600 IU/mL
* Liver biopsy consistent with chronic hepatitis C infection obtained within 2 years of enrollment
* Compensated liver disease without cirrhosis
* Participants with end-stage renal disease undergoing hemodialysis
* Negative serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
* All fertile participants must have been using effective contraception during treatment with study drug
Exclusion Criteria:
* Interferon therapy at any previous time
* Liver cirrhosis
* Signs and symptoms of hepatocellular carcinoma
* History or other evidence of decompensated liver disease
* Any investigational drug less than or equal to 6 weeks prior to the first dose of study drug
* History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
* Poorly controlled diabetes
* Thyroid dysfunction not adequately controlled
* Evidence of severe retinopathy or clinically relevant ophthalmological disorder
* Severe hyperparathyroidism defined as intact Parathyroid Hormone (PTH) \> 800 picogram/milliliter (pg/mL)
* Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment ≤ 6 months prior to the first dose of study drug
* Acute renal failure
* Women with ongoing pregnancy or breast feeding
* Positive test at screening for anti-HAV IgM Ab (hepatitis A virus immunoglobulin M antibody), hepatitis B surface antigen (HBsAg), anti-HBc (hepatitis B core) IgM Ab, anti-HIV (human immunodeficiency virus) Ab
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02806505
Study Brief:
Protocol Section:
NCT02806505