A Retrospective Study to Assess the Impact of the Use of Interferon in Patients With Chronic Hepatitis C (DECISION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01280656
First received: January 20, 2011
Last updated: October 13, 2014
Last verified: October 2014

January 20, 2011
October 13, 2014
January 2010
April 2012   (final data collection date for primary outcome measure)
  • Sustained virologic response (SVR) as defined by the percentage of patients with hepatitis C RNA <50IU/ml [ Time Frame: 12 weeks after end of treatment ] [ Designated as safety issue: No ]
  • Treatment discontinuation rate due to adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01280656 on ClinicalTrials.gov Archive Site
  • Treatment discontinuation rate due to adverse events between patients treated with different interferons [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Sustained virologic response (SVR) between patients treated with different interferons [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Interferon dose reduction rates in function of the interferon type being used [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Early virologic response (EVR) rates in function of the interferon type being used [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Comparison of sustained virologic response (SVR) of patients treated in interferon application centers and patients treated at home [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Comparison of treatment discontinuation rates of patients treated at interferon application centers and patients treated at home [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Relationship between sustained virologic response and hemoglobin drop [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Retrospective Study to Assess the Impact of the Use of Interferon in Patients With Chronic Hepatitis C (DECISION)
Retrospective Study to Access the Impact Caused by the Use of Interferon (Pegylated or Not) for the Treatment of Chronic Hepatitis C Patients in Brazil (DECISION)

This retrospective study will assess the sustained virologic response and the sa fety of two different interferons (pegylated or conventional) in patients with c hronic hepatitis C. Data will be collected for 24 weeks.

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

Hepatitis C patients that received interferon (pegylated or conventional) during the period stipulated (from 01-Sep-2007 to 31-Aug-2008)

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
660
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/=18 years and <70 years of age
  • Diagnosis of hepatitis C
  • Assessment of viral load prior to treatment (mandatory for genotype 1 only)
  • Liver biopsy
  • Co-morbidities data
  • Use of interferon (pegylated or conventional) and ribavirin to treat hepatitis C infection genotype 2 and 3 and pegylated interferon plus ribavirin to treat hepatitis C infection genotype 1
  • Above mentioned treatment started between 01-Sep-2007 and 31-Aug-2008

Exclusion Criteria:

  • Co-infection with human immunodeficiency virus (HIV)
  • Co-infection with hepatitis B virus (HBV)
  • Presence of hepatocarcinoma
  • Patients submitted to hemodialysis
  • Organ transplant patients
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01280656
ML22995
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

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