Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)(TERMINATED)

This study has been terminated.
(The study was terminated due to difficulty in recruiting participants.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00423800
First received: January 17, 2007
Last updated: June 2, 2014
Last verified: June 2014
Results First Received: January 27, 2011  
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
Intervention: Drug: Combination of pegylated interferon alfa-2b (PEG) and ribavirin (RBV)

  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
56 participants were enrolled. 51 participants were screening failures, were not randomized and are not included in the study. Of the 5 participants randomized, 2 did not meet inclusion/exclusion criteria. All 5 are included in the intent-to-treat (ITT) population.

Reporting Groups
  Description
Pegetron® - 24 Weeks Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
Pegetron® - 48 Weeks Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment

Participant Flow:   Overall Study
    Pegetron® - 24 Weeks     Pegetron® - 48 Weeks  
STARTED     3     2  
COMPLETED     3     1  
NOT COMPLETED     0     1  
Protocol Violation                 0                 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
Pegetron® - 24 Weeks Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
Pegetron® - 48 Weeks Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
Total Total of all reporting groups

Baseline Measures
    Pegetron® - 24 Weeks     Pegetron® - 48 Weeks     Total  
Number of Participants  
[units: participants]
  3     2     5  
Age  
[units: years]
Mean ± Standard Deviation
  54.0  ± 9.5     22  ± 0     41.2  ± 18.8  
Gender  
[units: participants]
     
Female     2     2     4  
Male     1     0     1  
Region of Enrollment  
[units: participants]
     
Canada     3     2     5  



  Outcome Measures
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1.  Primary:   Number of Participants With a Sustained Virologic Response   [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ]

2.  Secondary:   Number of Participants With a Virological Relapse   [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ]


  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
Due to the small sample size (n=5), no conclusions should be drawn.


  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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00423800     History of Changes
Other Study ID Numbers: P05016
Study First Received: January 17, 2007
Results First Received: January 27, 2011
Last Updated: June 2, 2014
Health Authority: Canada: Health Canada