Retreatment of chronic hepatitis C patients with pegylated interferon, ribavirin and amantadine; A pilot study to establishif initial drop in viral load is predictive for sustained virological response.
Completed
- Conditions
- Chronic hepatitis C infection
- Registration Number
- NL-OMON27702
- Lead Sponsor
- Schering-Plough
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 61
Inclusion Criteria
1. Patients with a chronic HCV infection, with virological relapse, or with virological non response to previous antiviral therapy diagnosed by:
a. anti-HCV positive;
Exclusion Criteria
1. Patients who are pregnant and patients (male or female) who are not willing to practise 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 are unwilling to have these tests done;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine if initial drop in viral load is predictive for virological sustained response.
- Secondary Outcome Measures
Name Time Method To determine if other co-factors i.e. viral load or HCV genotype are predictive for sustained virological response.