Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569AM2)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00048724
First received: November 6, 2002
Last updated: October 13, 2009
Last verified: October 2009
Results First Received: April 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Hepatitis C
Cirrhosis
Intervention: Biological: peginterferon alfa-2b (SCH 54031)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Analysis population is modified intent to treat (MITT), comprising 626 randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from analyses.

Reporting Groups
  Description
PegIntron PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
Untreated Control No text entered.

Participant Flow:   Overall Study
    PegIntron     Untreated Control  
STARTED     311     315  
COMPLETED     195     197  
NOT COMPLETED     116     118  
Adverse Event                 53                 12  
Withdrawal by Subject                 34                 54  
Lost to Follow-up                 5                 5  
Protocol-defined Clinical Event                 17                 32  
Noncompliance With Protocol                 4                 12  
Did Not Meet Protocol Eligibility                 2                 2  
Administrative                 1                 1  



  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
PegIntron PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
Untreated Control No text entered.
Total Total of all reporting groups

Baseline Measures
    PegIntron     Untreated Control     Total  
Number of Participants  
[units: participants]
  311     315     626  
Age, Customized  
[units: Participants]
     
<=50 years     130     132     262  
>50 years     181     183     364  
Gender  
[units: Participants]
     
Female     105     100     205  
Male     206     215     421  



  Outcome Measures
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1.  Primary:   Time to Observation of the First Clinical Event Experienced by a Subject   [ Time Frame: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event ]

2.  Secondary:   Time to Observation of the Disease Progression Experienced by a Subject   [ Time Frame: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event ]


  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
No text entered.  


Results Point of Contact:  
Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided by Schering-Plough

Publications automatically indexed to this study:

Responsible Party: Head, Clinical Trials Registry & Results Disclosure, Schering-Plough
ClinicalTrials.gov Identifier: NCT00048724     History of Changes
Other Study ID Numbers: P02569
Study First Received: November 6, 2002
Results First Received: April 23, 2009
Last Updated: October 13, 2009
Health Authority: United States: Food and Drug Administration