Status:
COMPLETED
Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients
Lead Sponsor:
UMC Utrecht
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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-)in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00146016
Start Date
February 1 2000
End Date
January 1 2007
Last Update
September 5 2005
Active Locations (1)
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1
UMC Utrecht
Utrecht, Utrecht, Netherlands, 3508 GA