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Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00048724
First received: November 6, 2002
Last updated: March 7, 2017
Last verified: March 2017
Results First Received: April 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 
Overall Participants Analyzed 
[Units: Participants]
 311   315   626 
Age, Customized 
[Units: Participants]
     
<=50 years   130   132   262 
>50 years   181   183   364 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      105  33.8%      100  31.7%      205  32.7% 
Male      206  66.2%      215  68.3%      421  67.3% 


  Outcome Measures
  Show All Outcome Measures

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


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck Sharp & Dohme Corp.
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: March 7, 2017