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Efficacy of PegIntron (Peginterferon Alfa-2b) and Rebetol (Ribavirin) in Treatment-naïve Subjects With Chronic Hepatitis C in Clinical Practice in Greece (Study P05209)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00724464
First received: July 25, 2008
Last updated: November 12, 2014
Last verified: November 2014
Results First Received: October 4, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Retrospective
Conditions: Hepatitis C, Chronic
Hepatitis C
Interventions: Biological: PegIntron (peginterferon alfa-2b, pegylated interferon alfa-2b)
Drug: Rebetol (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
401 participants were screened for eligibility. 332 participants were enrolled in the study.

Reporting Groups
  Description
Pegylated Interferon Alpha-2b and Ribavirin Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.

Participant Flow:   Overall Study
    Pegylated Interferon Alpha-2b and Ribavirin  
STARTED     332  
COMPLETED     309  
NOT COMPLETED     23  



  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
Pegylated Interferon Alpha-2b and Ribavirin Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.

Baseline Measures
    Pegylated Interferon Alpha-2b and Ribavirin  
Number of Participants  
[units: participants]
  332  
Age  
[units: years]
Mean ± Standard Deviation
  39.9  ± 11.8  
Gender  
[units: participants]
 
Female     102  
Male     230  



  Outcome Measures
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1.  Primary:   Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up   [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ]

2.  Primary:   Number of Participants Who Demonstrated Virological Relapse as Assessed at 24-week Post-treatment Follow-up   [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ]

3.  Secondary:   Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV Genotype at Baseline   [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ]

4.  Secondary:   Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Liver Fibrosis Stage at Baseline   [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ]

5.  Secondary:   Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV-RNA Viral Load at Baseline   [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ]

6.  Secondary:   Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Alanine Aminotransferase (ALT) Levels at Baseline   [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ]

7.  Secondary:   Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Study Treatment Dosage Modification   [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ]

8.  Secondary:   Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Achievement of Rapid Virological Response   [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ]

9.  Secondary:   Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Compliance With the 80/80/80 Rule   [ 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
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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


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00724464     History of Changes
Other Study ID Numbers: P05209
Study First Received: July 25, 2008
Results First Received: October 4, 2011
Last Updated: November 12, 2014
Health Authority: Greece: National Organization of Medicines