ATHENAS - Retrospective Study of Compliance in Chronic Hepatitis C With Pegylated Interferon Alfa-2b/Ribavirin in Brazil (Study P05632AM2)

This study has been terminated.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00856024
First received: March 4, 2009
Last updated: October 14, 2011
Last verified: October 2011
Results First Received: October 14, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Hepatitis C, Chronic
Interventions: Biological: 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
General Peginterferon + Ribavarin Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.

Participant Flow:   Overall Study
    General Peginterferon + Ribavarin  
STARTED     902  
COMPLETED     902  
NOT COMPLETED     0  



  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.
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Reporting Groups
  Description
General Peginterferon + Ribavarin Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.

Baseline Measures
    General Peginterferon + Ribavarin  
Number of Participants  
[units: participants]
  902  
Age [1]
[units: years]
Mean ± Standard Deviation
  49.9  ± 9.8  
Gender  
[units: participants]
 
Female     367  
Male     535  
Region of Enrollment  
[units: participants]
 
Brazil     902  
[1] Age data were only available for 900 participants



  Outcome Measures
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1.  Primary:   Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks   [ Time Frame: First 12 weeks of treatment ]

2.  Secondary:   Percent of Participants Who Achieved Rapid Virologic Response (RVR)   [ Time Frame: Week 4 ]

3.  Secondary:   Percent of Participants Who Achieved Early Virologic Response (EVR)   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
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Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClincialTrialsDisclosure@merck.com


No publications provided


Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00856024     History of Changes
Other Study ID Numbers: P05632, BR 002-07
Study First Received: March 4, 2009
Results First Received: October 14, 2011
Last Updated: October 14, 2011
Health Authority: Brazil: National Health Surveillance Agency