Real-life Surveillance Study of Patients With Chronic Hepatitis C Treated With PegIntron Injector and Rebetol (Study P04538)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00727311
First received: July 30, 2008
Last updated: April 28, 2014
Last verified: April 2014
Results First Received: December 22, 2010  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Hepatitis C, Chronic
Hepatitis C
Interventions: Biological: PegIntron (peginterferon alfa-2b; SCH 54031) injector
Drug: Rebetol (ribavirin; SCH 18908)

  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
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Reporting Groups
  Description
PegIntron + Rebetol

Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.

Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling.


Participant Flow:   Overall Study
    PegIntron + Rebetol  
STARTED     2302  
COMPLETED     1195  
NOT COMPLETED     1107  
Did not receive drug                 316  
Missing end of therapy data                 205  
Adverse Event                 58  
Lack of Efficacy                 242  
Lost to Follow-up                 73  
Withdrawal by Subject                 77  
not specified                 97  
Multiple reasons                 39  



  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
PegIntron + Rebetol

Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.

Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling.


Baseline Measures
    PegIntron + Rebetol  
Number of Participants  
[units: participants]
  2302  
Age [1]
[units: years]
Mean ± Standard Deviation
  42.1  ± 11.7  
Gender, Customized  
[units: participants]
 
Male     1169  
Female     766  
Gender information not captured     367  
Region of Enrollment  
[units: participants]
 
Germany     2302  
[1] Mean age was for the evaluable population of 1986 participants.



  Outcome Measures
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1.  Primary:   Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT)   [ Time Frame: 24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6 ]

2.  Primary:   Number of Participants With Early Virologic Response (EVR)   [ Time Frame: Treatment Week 12 ]

3.  Primary:   Number of Participants With Sustained Virologic Response (SVR)   [ Time Frame: 24 weeks post-treatment (Week 48 or 72, depending on genotype) ]

4.  Primary:   Number of HCV-RNA Negative Participants at Follow-up   [ Time Frame: 24 weeks post-treatment (Weeks 48 or 72, depending on genotype) ]


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


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00727311     History of Changes
Other Study ID Numbers: P04538
Study First Received: July 30, 2008
Results First Received: December 22, 2010
Last Updated: April 28, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices