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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
Results First Received: August 2, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Hepatitis C, Chronic
Interventions: Drug: Conventional Interferon
Drug: Peginterferon Alfa-2a
Drug: Peginterferon Alfa-2b
Drug: Ribavirin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 660 participants were enrolled from 39 centers in Brazil. The study was conducted from January 2010 to June 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Conventional Interferon Plus Ribavirin Eligible participants who received conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Peginterferon Alfa-2a Plus Ribavirin Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Peginterferon Alfa-2b Plus Ribavirin Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).

Participant Flow:   Overall Study
    Conventional Interferon Plus Ribavirin   Peginterferon Alfa-2a Plus Ribavirin   Peginterferon Alfa-2b Plus Ribavirin
STARTED   62   312   286 
COMPLETED   59   265   223 
NOT COMPLETED   3   47   63 
Adverse Event                1                14                13 
Lack of Efficacy                1                22                38 
Treatment shortening (RGT)                0                4                5 
Other                1                7                7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Conventional Interferon Plus Ribavirin Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Peginterferon Alfa-2a Plus Ribavirin Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Peginterferon Alfa-2b Plus Ribavirin Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
Total Total of all reporting groups

Baseline Measures
   Conventional Interferon Plus Ribavirin   Peginterferon Alfa-2a Plus Ribavirin   Peginterferon Alfa-2b Plus Ribavirin   Total 
Overall Participants Analyzed 
[Units: Participants]
 62   312   286   660 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.4  (8.6)   49.2  (10.7)   49.5  (9.5)   49.5  (10.0) 
Gender 
[Units: Participants]
       
Female   22   188   147   357 
Male   40   124   139   303 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment   [ Time Frame: At Week 60 ]

2.  Secondary:   Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment   [ Time Frame: At Week 72 ]

3.  Secondary:   Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used   [ Time Frame: At Week 24 ]

4.  Secondary:   Percentage of Participants With Early Virologic Response at Week 12   [ Time Frame: At Week 12 ]

5.  Secondary:   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) ]

6.  Secondary:   Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment   [ Time Frame: Up to Week 48 ]

7.  Secondary:   Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders   [ Time Frame: Up to Week 72 ]

8.  Secondary:   Percentage of Participants With Rapid Virologic Response at Week 4   [ Time Frame: At Week 4 ]

9.  Secondary:   Percentage of Participants With Virologic Response at End of Treatment   [ Time Frame: At Week 48 ]

10.  Secondary:   Percentage of Participants With Virologic Relapse up to Week 72   [ Time Frame: Up to Week 72 ]

11.  Secondary:   Percentage of Participants With Null Response or No Responder at End of Treatment   [ Time Frame: At Week 48 ]

12.  Secondary:   Percentage of Participants Who Discontinued Treatment Due to Adverse Events   [ Time Frame: Up to Week 48 ]

13.  Secondary:   Number of Participants With Any Adverse Events and Any Serious Adverse Events   [ Time Frame: Up to Week 72 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 61 6878333
e-mail: global.trial_information@roche.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01280656     History of Changes
Other Study ID Numbers: ML22995
Study First Received: January 20, 2011
Results First Received: August 2, 2016
Last Updated: October 6, 2016