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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT02027493
Eligibility Criteria:
Inclusion Criteria:
* children aged 3-19 years
* compensated chronic HCV infection (HCV-RNA positive by PCR for more than 6 months)
* whose hemoglobin was ≥10 g/dL
* neutrophilic count \> 1500/mm3
* platelet count \> 75,000/mm3
* normal random blood sugar
* normal serum creatinine
* normal serum ferritin
* normal thyroid function tests
* normal lipid profile
* no other causes of liver disease (autoimmune hepatitis, Wilson disease, alpha one antitrypsin deficiency nor hepatitis B virus infection).
* Liver biopsy was mandatory for enrollment
Exclusion Criteria:
* decompensated cirrhosis
* any other cause of liver disease associating HCV infection
* body mass index ≥ 95 percentile
* severe psychiatric conditions
* uncontrolled seizure disorder
* decompensated cardiovascular disease, renal insufficiency
* evidence of retinopathy
* decompensated thyroid disease
* hemoglobinopathy
* immunologically mediated diseases or any other chronic illness requiring long term immunosuppressive drugs
* previous interferon therapy within one year of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
19 Years
Study:
NCT02027493
Study Brief:
Protocol Section:
NCT02027493