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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01200225
First received: September 10, 2010
Last updated: July 7, 2014
Last verified: July 2014

September 10, 2010
July 7, 2014
February 2010
June 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01200225 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

This prospective observational study will assess the insulin resistance and its impact on sustained virological response in patients with hepatitis C treated wi th Pegasys and Copegus. Data will be collected from each patient during the up t

o 72 weeks of treatment and for 24 weeks of treatment-free follow-up.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with inadequate response or intolerant to DMARDs and anti-TNF

Hepatitis C, Chronic
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1155
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01200225
ML22790
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP