Study on chronic hepatitis C treatment with interferon alpha, ribavirin and amantadine in naive patients.

niversity Medical Centre Utrecht (UMCU) (Netherlands)0 sites390 target enrollmentDecember 20, 2005

Overview

No summary available.

Registry

who.int

Start Date

December 20, 2005

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity Medical Centre Utrecht (UMCU) (Netherlands)

•1\. Anti\-HCV positivity; greater than 6 months
•2\. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) elevation on at least once in the previous 6 months
•3\. Positive hepatitis C virus ribonucleic acide (HCV\-RNA)
•4\. Liver biopsy within one year before the start of therapy in non\-cirrhosis. In the case of known cirrhosis, liver biopsy is not necessary.
•5\. Intention to be treated and participate treatment
•6\. Obtained written informed consent

•1\. Aged less than 18 years
•2\. 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
•3\. Men not practicing or willing to practice acceptable methods of contraception during the treatment period and up to 6 months after discontinuation of therapy
•4\. Life expectancy less than 1 year
•5\. Child Pugh B or C (Appendix III)
•6\. Creatinine greater than 150 µmol/L or greater than 170 mg/dl
•7\. Haemoglobin less than 65 mmol/l or less than 105 g/dl, white blood cell count less than 2\.5 x 10^9/L, neutrophil less than 1\.5 x 10^9/L, platelet count less than 70 x 10^9/L
•8\. Human immunodeficiency virus (HIV) positivity
•9\. Chemotherapy, systemical antiviral treatment during the 6 months prior to study entry
•10\. Other serious disease (e.g. malignancy, uncontrolled myocardial disease or severe arrhythmias)