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 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT03721627
Eligibility Criteria:
Inclusion Criteria:
* Aged 6 to \<18 years
* Parent or legal guardian must provide written informed consent
* Treatment naïve or experienced children with chronic HCV infection
* Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
* Screening laboratory values within defined thresholds
* No History of solid organ or bone marrow transplantation
* No history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
Exclusion Criteria:
* Patients with other sever comorbidities of chronic medical illness (e.g. decompensated heart disease, chronic kidney insufficiency)
* Concomitant hepatitis B virus (HBV) or Human immunodeficiency virus (HIV) infection
* Medications (systemic steroids, immunosuppressives)
* Patients or guardians who are unwilling to participate or sign informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT03721627
Study Brief:
Protocol Section:
NCT03721627