Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients
Chronic Hepatitis C
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic Hepatitis C, Amantadine, Triple therapy
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
Sites / Locations
- UMC Utrecht