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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 6, 2016
Last verified: October 2016

January 20, 2011
October 6, 2016
January 2010
November 2012   (final data collection date for primary outcome measure)
Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment [ Time Frame: At Week 60 ] [ Designated as safety issue: No ]
Sustained virological response (SVR) was defined as virological response at 12 weeks after end of treatment (EOT). Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants' plasma samples) or less than 50 international units/milliliter (IU/mL) HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). EOT= Week 48. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.
  • 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 ]
Complete list of historical versions of study NCT01280656 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment [ Time Frame: At Week 72 ] [ Designated as safety issue: No ]
    SVR was defined as virological response at 24 weeks after EOT, EOT= Week 48. Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants' plasma samples) or less than 50 IU/mL HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.
  • Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
    The number of participants with Interferon dose reduction rates in function of the interferon type being used are reported
  • Percentage of Participants With Early Virologic Response at Week 12 [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
    An early virologic response (EVR) was defined as a HCV-RNA decrease of at least two logarithmic scales (2 Log) or 100 times the pretreatment value or non-detection at Week 12 of treatment period.
  • Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home [ Time Frame: At Week 60 (SVR 12) and Week 72 (SVR 24) ] [ Designated as safety issue: No ]
    The percentage of participants with SVR-12 and SVR-24 treated at interferon application centers (IAC) and treated at home are presented.
  • Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants who were treated at interferon application centers and at home and who discontinued treatment is presented. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.
  • Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders [ Time Frame: Up to Week 72 ] [ Designated as safety issue: No ]
    The average percentage reduction of hemoglobin (Hb) in treatment responders and treatment non-responders between the conventional group, peginterferon alfa-2a plus and peginterferon alfa-2b is presented. Participants with undetectable HCV RNA at specified time points (Weeks 4/12/18/24/48) were considered as treatment responders. Participants with positive viral load (detectable HCV RNA) at end of treatment regardless of the treatment duration were considered as treatment non-responders.
  • Percentage of Participants With Rapid Virologic Response at Week 4 [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]
    Rapid virologic response was defined as qualitative or quantitative HCV-RNA (viral load) undetectable (below the lower limit of detection) at Week 4 of treatment period.
  • Percentage of Participants With Virologic Response at End of Treatment [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
    Virologic response at EOT was defined as undetectable HCV-RNA at EOT (regardless in which week treatment was concluded). EOT = Week 48.
  • Percentage of Participants With Virologic Relapse up to Week 72 [ Time Frame: Up to Week 72 ] [ Designated as safety issue: No ]
    Virologic relapse was defined as undetectable HCV-RNA at end of treatment and detectable HCV-RNA at the last follow-up assessment available. If the participant was a responder at end of treatment and was not submitted to any viral load assessment during the follow-up period, he was considered a relapser.
  • Percentage of Participants With Null Response or No Responder at End of Treatment [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
    Null response or no responders were defined as those participants presenting positive viral load at EOT (regardless of the treatment duration). EOT= Week 48.
  • Percentage of Participants Who Discontinued Treatment Due to Adverse Events [ Time Frame: Up to Week 48 ] [ Designated as safety issue: Yes ]
    The percentage of participants with treatment discontinuation rates due to adverse events (AE) between conventional group, peginterferon alfa-2a and peginterferon alfa-2b is presented.
  • Number of Participants With Any Adverse Events and Any Serious Adverse Events [ Time Frame: Up to Week 72 ] [ Designated as safety issue: Yes ]
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.
  • 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 ]
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 Evaluate the Impact of Using Interferon (Pegylated or Not) in the Treatment of Patients With Chronic Hepatitis C in Brazil (DECISION)
This retrospective study will assess the sustained virologic response and the safety of two different interferons (pegylated or conventional) in patients with chronic 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
  • Drug: Conventional Interferon
    Conventional interferon according to the standard of care and aligned with the local prescription instructions
  • Drug: Peginterferon Alfa-2a
    Peginterferon alfa-2a according to the standard of care and aligned with the local prescription instructions
  • Drug: Peginterferon Alfa-2b
    Peginterferon alfa-2b according to the standard of care and aligned with the local prescription instructions
  • Drug: Ribavirin
    Ribavirin according to the standard of care and aligned with the local prescription instructions
  • Conventional Interferon Plus Ribavirin
    Eligible participants who will receive conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).
    Interventions:
    • Drug: Conventional Interferon
    • Drug: Ribavirin
  • Peginterferon Alfa-2a Plus Ribavirin
    Eligible participants who will receive peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).
    Interventions:
    • Drug: Peginterferon Alfa-2a
    • Drug: Ribavirin
  • Peginterferon Alfa-2b Plus Ribavirin
    Eligible participants who will receive peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).
    Interventions:
    • Drug: Peginterferon Alfa-2b
    • Drug: Ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
660
June 2013
November 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
  • Co-infection with hepatitis B virus
  • Presence of hepatocarcinoma
  • Patients submitted to hemodialysis
  • Organ transplant patients
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01280656
ML22995
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2016

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