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Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00725751
First received: July 25, 2008
Last updated: October 31, 2014
Last verified: October 2014
Results First Received: March 23, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Hepatitis C, Chronic
Interventions: Biological: Pegylated interferon alfa-2b (PegIFN-2b)
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
353 participants were enrolled on the study; 348 were treated.

Reporting Groups
  Description
PegIFN-2b/Ribavirin With Substitution Therapy Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
PegIFN-2b/Ribavirin Without Substitution Therapy Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)

Participant Flow:   Overall Study
    PegIFN-2b/Ribavirin With Substitution Therapy     PegIFN-2b/Ribavirin Without Substitution Therapy  
STARTED     90     258  
COMPLETED     56     150  
NOT COMPLETED     34     108  



  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
PegIFN-2b/Ribavirin With Substitution Therapy Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
PegIFN-2b/Ribavirin Without Substitution Therapy Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
Total Total of all reporting groups

Baseline Measures
    PegIFN-2b/Ribavirin With Substitution Therapy     PegIFN-2b/Ribavirin Without Substitution Therapy     Total  
Number of Participants  
[units: participants]
  90     258     348  
Age  
[units: years]
Mean ± Standard Deviation
  32.38  ± 9.51     42.26  ± 12.62     39.71  ± 12.64  
Gender  
[units: participants]
     
Female     29     96     125  
Male     61     162     223  
Region of Enrollment  
[units: participants]
     
Austria     90     258     348  



  Outcome Measures
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1.  Primary:   Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin   [ Time Frame: 24 to 48 weeks ]

2.  Secondary:   Number of Participants Who Achieved Sustained Virologic Response (SVR)   [ Time Frame: 24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype) ]

3.  Secondary:   Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy   [ Time Frame: Day 1 ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725751     History of Changes
Other Study ID Numbers: P05255
Study First Received: July 25, 2008
Results First Received: March 23, 2012
Last Updated: October 31, 2014
Health Authority: Austria: Not applicable