Interferon induction followed by PEG-interferon combined with ribavirin and amantadine for treatment of naive chronic hepatitis C patients with genotype 1 or 4.
Completed
- Conditions
- chronic hepatitis C
- Registration Number
- NL-OMON27278
- Lead Sponsor
- AMC Liver Center, Department GastroAcademic Medical Center, University of Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 58
Inclusion Criteria
1. Patients which are serum HCV-RNA positive by PCR and with genotype 1 or 4;
2. Patients who never have used antiviral therapy for chronic hepatitis C;
Exclusion Criteria
1. Patients who are pregnant and patients (male or female) who are not willing to practice adequate contraception during the treatment period and up to 6 months after ending the treatment period;
2. Patients who are HBsAg or HIV antibody positive or who are unwilling to have these tests done;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sustained virological response (HCV RNA undetectable 24 weeks after cessation of treatment).
- Secondary Outcome Measures
Name Time Method Early viral kinetics vs outcome<br>immunological parameters during treatment (correlation with outcome) liver fibrosis before and after Rx.