Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chronic Hepatitis C
- Sponsor
- UMC Utrecht
- Enrollment
- 390
- Locations
- 1
- Primary Endpoint
- Response rate at end of treatment and end of follow-up (sustained response rate)
- Status
- Completed
- Last Updated
- 20 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Response rate at end of treatment and end of follow-up (sustained response rate)