An Observational Study on Predictive Factors of Response in Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Ribavirin

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01392742
First received: July 11, 2011
Last updated: April 7, 2014
Last verified: April 2014

July 11, 2011
April 7, 2014
May 2011
August 2014   (final data collection date for primary outcome measure)
Correlation of sustained virological response (SVR: undetectable HCV RNA 24 weeks after end of treatment) with rapid and early virological response [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01392742 on ClinicalTrials.gov Archive Site
  • Correlation of baseline host factors and virological response (HCV RNA levels) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Correlation of cumulative Pegasys/ribavirin dose and sustained virological response (SVR) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Relapse rate 24 weeks post-treatment [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Study on Predictive Factors of Response in Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Ribavirin
Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in HCV-infected Patients Receiving Peginterferon Alfa-2a Plus Ribavirin

This observational study will evaluate predictors of early on-treatment response and sustained virological response in patients with chronic hepatitis C receiving Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected from patients on treatment (24 or 48 weeks) and 24 weeks after the end of treatment.

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

Patients with chronic hepatitis C treated with Pegasys and ribavirin

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.
 
Active, not recruiting
443
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Serologically confirmed chronic hepatitis C (all genotypes)
  • Treatment with Pegasys and ribavirin according to the current standard of care and in line with current summaries of product characteristics (SPCs)/local labelling

Exclusion Criteria:

  • Coinfection with HIV and/or hepatitis B
  • Contraindications according to the SPC for Pegasys/ribavirin
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria
 
NCT01392742
ML25670
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

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