Clinical Trial Protocol Registry

Trial information

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)

Status:
Completed
Protocol number:
ML22790
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Official Scientific 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
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. Target sample size is 1155.
Study phase:
IV
Study type:
Observational study
Conditions:
  • Hepatitis C, Chronic
Primary outcome:
  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
Key secondary outcomes:
  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
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
Gender:
Males or Females
Age limits:
Min: 18 years Max: N/A (No limit)
Accepts healthy volunteers:
No
Anticipated start date:
February, 2010
Trial registration date:
25.08.2010
Date last updated:
10.06.2013
This trial was conducted at the following locations:
France
  • NEUILLY-SUR-SEINE

Link to trial result

For more information on a specific Roche trials in your country location, please contact your local Roche affiliate nearest you.

  • Go on the URL link- http://www.roche.com and click on the Roche Worldwide tab on the top of the page to locate the country nearest you for contact information.

Treatment decisions and/or suitability for a specific trial are decisions only your healthcare provider can make. If you are patient interested in any of the global studies, please have your healthcare provider contact us and they will be provided with the relevant clinical trial information.

For US or global trials with US sites only, please contact the Trial Information Support Line (TISL)