Chronic Hepatitis C
Conditions
Keywords
Chronic Hepatitis C, Amantadine, Triple therapy
Brief summary
\* Adding Amantadine to standard anti-viral treatment can improve sustained response rates in patients with chronic hepatitis C
Detailed description
The CIRA-study is a double blind, placebo controlled, randomised, multicentre study in previously untreated patients suffering from chronic hepatitis C comparing double therapy, consisting of (PEG-)interferon alpha 2b ((PEG)Intron-A®) and ribavirin (Rebetol®), with triple therapy, consisting of (PEG-)interferon alpha 2b, ribavirin and amantadine, for 52 weeks. Follow-up is completed at week 104. 150 Subjects per treatment group will be included. Patients will be stratified before randomisation according to genotype (1 versus non-1). Viral load will not be a discriminating factor. The aim is to investigate the efficacy of the adjunct amantadine to the currently used combination therapy with interferon alpha and ribavirin.
Interventions
DRUGAmantadine
Sponsors
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate at end of treatment and end of follow-up (sustained response rate) | — |
Countries
Netherlands
Outcome results
None listed