Prospective Observational Study to Asses the Insulin Resistance (IR) and Its Impact on Sustained Virological Response in a Cohort of HCV-infected Patients Treated With Pegasys and Copegus

Hoffmann-La Roche0 sites1,155 target enrollmentFebruary 2010

ConditionsHepatitis C, Chronic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Enrollment: 1155
Primary Endpoint: Effect of insulin resistance, defined as HOMA index > 2, on sustained virological response (HCV RNA assessed by Polymerase Chain Reaction assay)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

June 2013

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients, \>/= 18 years of age
•Chronic hepatitis C (detectable HCV RNA)
•Initiation of treatment with Pegasys and Copegus

Exclusion Criteria

•Participation in a clinical trial during the study

Outcomes

Primary Outcomes

Effect of insulin resistance, defined as HOMA index > 2, on sustained virological response (HCV RNA assessed by Polymerase Chain Reaction assay)

Time Frame: 42 months

Secondary Outcomes

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)