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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01200225
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease
Hepatitis C, Chronic

Study Type : Observational
Actual Enrollment : 1155 participants
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
Study Start Date : February 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Host-, virus- and treatment-related factors influencing virological response and sustained virological response [ Time Frame: 42 months ]
  2. Parameters of metabolic syndrome [ Time Frame: 42 months ]
  3. Management of insulin resistance [ Time Frame: 42 months ]
  4. Quality of life: Hepatitis Quality of Life Questionnaire (HQLQ) [ Time Frame: 42 months ]
  5. Safety: Incidence of adverse events [ Time Frame: 42 months ]
  6. Patient characteristics [ Time Frame: 42 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01200225

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

Responsible Party: Hoffmann-La Roche Identifier: NCT01200225     History of Changes
Other Study ID Numbers: ML22790
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Hepatitis C
Insulin Resistance
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Glucose Metabolism Disorders
Metabolic Diseases
Hepatitis, Chronic
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents