An observational study in Hepatitis C, Chronic, sponsored by Hoffmann-La Roche. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Observational
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.
2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 1,155 is above the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with inadequate response or intolerant to DMARDs and anti-TNF
Exclusion Criteria:
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
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
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hoffmann-La Roche