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 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT00709059
Eligibility Criteria:
Inclusion Criteria:
* Previously untreated ('treatment naïve') adults (18 year or more) for whom the treating physician has decided to start treatment with PegIntron and Rebetol
* Detectable Hepatitis C Virus - Ribonucleic Acid (HCV-RNA) in serum by Polymerase Chain Reaction (PCR)
* Repeated (with at least a 1 month interval) serum transaminase (alanine aminotransferase \[ALT\]) levels above the upper normal limit for gender
* Documented chronic hepatitis C (CHC) of genotype 1/4/5/6
* A representative liver biopsy within 1 year prior to inclusion, allowing fibrosis grading into METAVIR score F0, F1, F2, F3 or F4
Exclusion Criteria:
* Known hypersensitivity for any active ingredient or constituent
* Pregnancy or lactation
* Medically documented history of severe psychiatric disturbance, including severe depression, suicidal ideation or suicide attempt
* Medically documented history of severe heart disease, including unstable or uncontrolled cardiac disease, within the last 6 months
* Severely weakening medical condition, including chronic renal insufficiency or creatinine clearance \<50 mL/minute
* Hepatitis of immunologic origin or medically documented history of auto-immune disease
* Severe hepatic disorder or decompensated cirrhosis
* Pre-existing thyroid disorder, except if under control with classical treatment
* Epilepsy or central nervous system disorder
* Hemoglobin pathology, eg, thalassaemia, sickle cell anemia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00709059
Study Brief:
Protocol Section:
NCT00709059