Relapse Rate in Hepatitis C Patients Treated With Peginterferon Alfa-2b Plus Ribavirin in Common Clinical Practice in France (P05484)(Completed) (RE-CHUT)

This study has been terminated.
(Low enrollment)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00725842
First received: July 28, 2008
Last updated: October 22, 2013
Last verified: October 2013
Results First Received: June 13, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Hepatitis C
Hepatitis C, Chronic
Interventions: Biological: Peg-IFN alfa-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
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Reporting Groups
  Description
Peg-IFN Alfa-2b + Ribavirin Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).

Participant Flow:   Overall Study
    Peg-IFN Alfa-2b + Ribavirin  
STARTED     97  
Participants Eligible for Analysis     90  
COMPLETED     57  
NOT COMPLETED     40  
Lost to Follow-up                 19  
Death                 1  
Positive HCV-RNA at Visit 2                 13  
Consent date prior to study start date                 5  
Inclusion criterion not met                 1  
No Visit 1 data                 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
Peg-IFN Alfa-2b + Ribavirin Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).

Baseline Measures
    Peg-IFN Alfa-2b + Ribavirin  
Number of Participants  
[units: participants]
  90  
Age [1]
[units: years]
Mean ± Standard Deviation
  46.0  ± 12.5  
Gender [2]
[units: participants]
 
Female     25  
Male     65  
[1] Age data unavailable for the 7 participants excluded from analysis.
[2] Gender data unavailable for the 7 participants excluded from analysis.



  Outcome Measures
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1.  Primary:   Number of Participants With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment   [ Time Frame: 24 weeks post end of treatment (EOT) ]

2.  Secondary:   Number of Participants With Rapid Virologic Response (RVR), Early Virologic Response (EVR), or Slow Response Who Relapsed After Treatment   [ Time Frame: 24 weeks post EOT ]

3.  Secondary:   Assessment of Pre-treatment Risk Factors of Relapse in Participants With Sustained Virologic Response   [ Time Frame: Baseline and 24 weeks post EOT ]

4.  Secondary:   Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment   [ Time Frame: 72 weeks post EOT ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
Due to low enrollment some planned analyses were not performed.  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725842     History of Changes
Other Study ID Numbers: P05484
Study First Received: July 28, 2008
Results First Received: June 13, 2012
Last Updated: October 22, 2013
Health Authority: France: Physicians National Council