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:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT03665766
Eligibility Criteria:
Inclusion Criteria:group(I):participants received Peg IFN-α 2a and RBV therapy who fulfilled the following inclusion criteria:
* Age between 18 and 65 years ;
* elevated aminotransferase levels (ALT and AST)
* detectable HCV RNA by polymerase chain reaction (PCR)
* liver biopsy results consistent with HCV recurrence using the Metavir scoring system (Metavir ≥A1F1)
* For group II and III:
* age between 18 and 75 years
* detectable HCV RNA by PCR
Exclusion Criteria:group I
* if they were younger than 18 years or older than 65 years or had one of the following criteria
* alcoholic
* poorly controlled autoimmune disease
* significant cardiac disease
* suicidal ideation
* a history of suicide attempt
* major psychosis
* serum creatinine ˃3 mg/dl
* thyroid dysfunction
* combined kidney-liver transplantation
* were currently pregnant or planning pregnancy.
Group II and III:
* younger than 18 years or older than 75 years
* total bilirubin (T.Bil) \>3 mg/dl
* serum albumin\< 2.8 mg/dl
* international normalized ratio ≥1.7
* Platelet count \< 5000/mm3
* HCC, except 4 weeks after intervention with no evidence of activity using computed tomography or magnetic resonance imaging
* extra hepatic malignancy except after two years of disease free-interval
* uncontrolled diabetes evidenced by glycated haemoglobin \>9%
* were pregnant .
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03665766
Study Brief:
Protocol Section:
NCT03665766