Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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 1, 2015
Last verified: October 2015
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  Hide 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.


  More Information
  Hide More Information

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



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 1, 2015