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)

N/ACompletedNCT01200225

Hoffmann-La Roche1,155 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,155

Conditions

Hepatitis C, Chronic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Neuilly-sur-Seine, France

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

Host-, virus- and treatment-related factors influencing virological response and sustained virological response

Time frame: 42 months

Parameters of metabolic syndrome

Time frame: 42 months

Management of insulin resistance

Time frame: 42 months

Quality of life: Hepatitis Quality of Life Questionnaire (HQLQ)

Time frame: 42 months

Safety: Incidence of adverse events

Time frame: 42 months

Patient characteristics

Time frame: 42 months

Data from ClinicalTrials.gov

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