We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01200225
First Posted: September 13, 2010
Last Update Posted: November 2, 2016
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
September 10, 2010
September 13, 2010
November 2, 2016
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 ]
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 ]
  • Parameters of metabolic syndrome [ Time Frame: 42 months ]
  • Management of insulin resistance [ Time Frame: 42 months ]
  • Quality of life: Hepatitis Quality of Life Questionnaire (HQLQ) [ Time Frame: 42 months ]
  • Safety: Incidence of adverse events [ Time Frame: 42 months ]
  • Patient characteristics [ Time Frame: 42 months ]
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 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.
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01200225
ML22790
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016