Treatment of Patients With Chronic Hepatitis C With PegIntron as Monotherapy or in Combination With Ribavirin (Study P04437)(COMPLETED) (ADEQUATION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00705666
First received: June 23, 2008
Last updated: October 16, 2013
Last verified: October 2013
Results First Received: March 30, 2010  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Hepatitis C, Chronic
Hepacivirus
Interventions: Biological: Peginterferon alfa-2b (SCH 54031)
Drug: Ribavirin (SCH 18908)

  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
PegIntron as Monotherapy or in Combination With Ribavirin Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.

Participant Flow:   Overall Study
    PegIntron as Monotherapy or in Combination With Ribavirin  
STARTED     789  
COMPLETED     450  
NOT COMPLETED     339  
No post-treatment questionnaire                 279  
Withdrawal by Subject                 21  
Physician Decision                 7  
Lost to Follow-up                 5  
Death                 1  
Adverse Event                 4  
Not specified                 12  
Unknown                 2  
Lack of data                 3  
Untreated                 5  



  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
PegIntron as Monotherapy or in Combination With Ribavirin Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.

Baseline Measures
    PegIntron as Monotherapy or in Combination With Ribavirin  
Number of Participants  
[units: participants]
  789  
Age, Customized  
[units: years]
Mean ± Standard Deviation
  49  ± 12.1  
Gender, Customized [1]
[units: participants]
 
Female     296  
Male     485  
Unavailable     8  
Region of Enrollment  
[units: participants]
 
France     789  
[1] Gender is provided for the patients that were included in the analysis (781); gender is unknown for the eight (8) participants that were not included in the analysis.



  Outcome Measures

1.  Primary:   The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting).   [ Time Frame: Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for participants treated for 48 weeks. ]


  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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00705666     History of Changes
Other Study ID Numbers: P04437
Study First Received: June 23, 2008
Results First Received: March 30, 2010
Last Updated: October 16, 2013
Health Authority: France: Not Applicable