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)

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01200225
• Other study ID #: ML22790
• Status: Completed
• Phase: N/A
• First received: September 10, 2010
• Last updated: November 1, 2016
• Start date: February 2010
• Est. completion date: June 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission Nationale de L'informatique et des Libertes
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1155
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Insulin Resistance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of insulin resistance, defined as HOMA index > 2, on sustained virological response (HCV RNA assessed by Polymerase Chain Reaction assay)		42 months	No
Secondary	Host-, virus- and treatment-related factors influencing virological response and sustained virological response		42 months	No
Secondary	Parameters of metabolic syndrome		42 months	No
Secondary	Management of insulin resistance		42 months	No
Secondary	Quality of life: Hepatitis Quality of Life Questionnaire (HQLQ)		42 months	No
Secondary	Safety: Incidence of adverse events		42 months	No
Secondary	Patient characteristics		42 months	No