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)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01200225

Enrollment

1155

Registered

2010-09-13

Start date

2010-02-28

Completion date

2013-06-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Effect of insulin resistance, defined as HOMA index > 2, on sustained virological response (HCV RNA assessed by Polymerase Chain Reaction assay)	42 months

Secondary

Measure	Time frame
Parameters of metabolic syndrome	42 months
Management of insulin resistance	42 months
Host-, virus- and treatment-related factors influencing virological response and sustained virological response	42 months
Safety: Incidence of adverse events	42 months
Patient characteristics	42 months
Quality of life: Hepatitis Quality of Life Questionnaire (HQLQ)	42 months

Countries

France

Outcome results