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Peg-Intron/Ribavirin in G 1 HCV for Non-Extended Versus 24 Week Extended Treatment After 24 Weeks (Study P04144)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00202839
First received: September 12, 2005
Last updated: February 25, 2011
Last verified: February 2011
History of Changes
Results First Received: August 28, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
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
24-Week Treatment Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
48-Week Treatment Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)

Participant Flow:   Overall Study
    24-Week Treatment     48-Week Treatment  
STARTED     78     82  
COMPLETED     54     72  
NOT COMPLETED     24     10  
Adverse Event                 1                 5  
Physician Decision                 12                 0  
Withdrawal by Subject                 6                 2  
Protocol Violation                 2                 1  
Lost to Follow-up                 3                 2  



  Baseline Characteristics
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Reporting Groups
  Description
24-Week Treatment Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
48-Week Treatment Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
Total Total of all reporting groups

Baseline Measures
    24-Week Treatment     48-Week Treatment     Total  
Number of Participants  
[units: participants]
 		  78     82     160  
Age  
[units: years]
Mean ± Standard Deviation 		  50.63  ± 10.6     50.46  ± 10.93     50.55  ± 10.74  
Gender  
[units: participants]
 		     
Female     20     39     59  
Male     58     43     101  
Region of Enrollment  
[units: participants]
 		     
Taiwan     78     82     160  



  Outcome Measures
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1.  Primary:   The Percentage of Participants Who Achieved a Sustained Virologic Response (SVR)   [ Time Frame: 24 weeks of follow-up after either 24 or 48 weeks of anti-HCV therapy ]
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2.  Secondary:   The Percentage of Participants Who Achieved a Virologic Response 48 Weeks After Randomization.   [ Time Frame: 48 weeks after randomization (with 24 weeks of treatment immediately before randomization and either 0 or 24 weeks of treatment immediately after randomization) ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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