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)

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: September 10, 2010
Last updated: May 4, 2016
Last verified: May 2016
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.

Hepatitis C, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Host-, virus- and treatment-related factors influencing virological response and sustained virological response [ Time Frame: 42 months ] [ Designated as safety issue: No ]
  • Parameters of metabolic syndrome [ Time Frame: 42 months ] [ Designated as safety issue: No ]
  • Management of insulin resistance [ Time Frame: 42 months ] [ Designated as safety issue: No ]
  • Quality of life: Hepatitis Quality of Life Questionnaire (HQLQ) [ Time Frame: 42 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 42 months ] [ Designated as safety issue: No ]
  • Patient characteristics [ Time Frame: 42 months ] [ Designated as safety issue: No ]

Enrollment: 1155
Study Start Date: February 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with inadequate response or intolerant to DMARDs and anti-TNF

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01200225

Neuilly-sur-seine, France, 92521
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01200225     History of Changes
Other Study ID Numbers: ML22790 
Study First Received: September 10, 2010
Last Updated: May 4, 2016
Health Authority: France: Commission Nationale de L'informatique et des Libertes

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Insulin Resistance
Digestive System Diseases
Flaviviridae Infections
Glucose Metabolism Disorders
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Metabolic Diseases
RNA Virus Infections
Virus Diseases processed this record on May 26, 2016