An Observational Study on The Impact of Insulin Resistance on Sustained Virological Response in Patients With Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
Completed
- Conditions
- Hepatitis C, Chronic
- Registration Number
- NCT01200225
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This prospective observational study will assess the insulin resistance and its impact on sustained virological response in patients with hepatitis C treated with Pegasys and Copegus. Data will be collected from each patient during the up to 72 weeks of treatment and for 24 weeks of treatment-free follow-up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1155
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Chronic hepatitis C (detectable HCV RNA)
- Initiation of treatment with Pegasys and Copegus
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Exclusion Criteria
- Participation in a clinical trial during the study
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of insulin resistance, defined as HOMA index > 2, on sustained virological response (HCV RNA assessed by Polymerase Chain Reaction assay) 42 months
- Secondary Outcome Measures
Name Time Method Quality of life: Hepatitis Quality of Life Questionnaire (HQLQ) 42 months Safety: Incidence of adverse events 42 months Host-, virus- and treatment-related factors influencing virological response and sustained virological response 42 months Parameters of metabolic syndrome 42 months Management of insulin resistance 42 months Patient characteristics 42 months