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:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT00146016
Eligibility Criteria:
Inclusion Criteria:
* Anti-HCV positivity \>6 months
* ALT and/or AST elevation on at least once in the previous 6 months
* Positive HCV-RNA
* Liver biopsy within one year before the start of therapy in non- cirrhosis. In the case of known cirrhosis, liver biopsy is not necessary
* Intention to be treated and participate treatment
* Obtained written informed consent
Exclusion Criteria:
* Age \< 18 years
* Pregnancy or intention to get pregnant within the 12 months period of treatment and up to 6 months after discontinuation of therapy, no adequate contraception, lactation
* Men not practicing or willing to practice acceptable methods of contraception during the treatment period and up to 6 months after discontinuation of therapy
* Life expectancy \< 1 year
* Child Pugh B or C (Appendix III)
* Creatinine \> 150 μmol/L or \> 1.70 mg/dl
* Haemoglobulin \< 6.5 mmol/l or \< 10.5 g/dl
* White blood cell count \< 2,5 x 109/L, neutrophil \< 1,5 x 109/L
* Platelet count \< 70 x 109/L
* HIV positivity
* Chemotherapy, systematical antiviral treatment during the 6 months prior to study entry
* Other serious disease (e.g. malignancy, uncontrolled myocardial disease or severe arrhythmias)
* Active uncontrolled psychiatric disorders and suicidal leanings
* Patients with a history of uncontrolled seizure or other significant CNS dysfunction
* Any condition which in the opinion of the (co-)investigator might interfere with the evaluation of the study objectives
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00146016
Study Brief:
Protocol Section:
NCT00146016