An Observational Study on Predictive Factors of Response in Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Ribavirin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01392742
First received: July 11, 2011
Last updated: November 9, 2015
Last verified: November 2015
Results First Received: November 9, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Hepatitis C, Chronic

  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
Hepatitis C Virus (HCV) Infected Participants Participants who were infected by HCV and receiving pegylated interferon alfa-2a (PEG-IFN alfa-2a) 180 micrograms per week (µg/week) subcutaneously, plus ribavirin tablets 1000 milligrams (mg) (those weighing less than [<] 75 kilograms [kg]) or 1200 mg (those weighing greater than [>] 75 kg) orally; were observed for approximately up to 24 weeks after end of treatment (EOT). Dose change was as per investigators’ discretion.

Participant Flow:   Overall Study
    Hepatitis C Virus (HCV) Infected Participants  
STARTED     443  
COMPLETED     242  
NOT COMPLETED     201  
Premature study termination                 42  
Failure to return                 35  
No treatment/no cooperation/withdrew                 12  
Lost to Follow-up                 34  
Insufficient therapeutic response (ITR)                 30  
ITR and Protocol deviation                 1  
Adverse event/intercurrent illness                 17  
Protocol Violation                 14  
Unspecified                 3  
Missing information                 13  



  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.
Intent-to-treat (ITT) population included all screened participants.

Reporting Groups
  Description
HCV Infected Participants Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.

Baseline Measures
    HCV Infected Participants  
Number of Participants  
[units: participants]
  443  
Age  
[units: years]
Mean (Standard Deviation)
  40.61  (12.32)  
Gender  
[units: participants]
 
Female     182  
Male     261  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Sustained Virological Response (SVR)   [ Time Frame: 24 weeks after End of treatment (EOT) (up to Week 96) ]

2.  Primary:   Percentage of Participants With Relapse   [ Time Frame: Up to 24 weeks after EOT (up to Week 96) ]

3.  Primary:   Percentage of Participants Who Were Non-Responders   [ Time Frame: Up to 24 weeks after EOT (up to Week 96) ]

4.  Secondary:   Percentage of Participants With Positive Predictive Value on SVR at Week 4   [ Time Frame: Week 4 ]

5.  Secondary:   Percentage of Participants With Positive Predictive Value on SVR at Week 12   [ Time Frame: Week 12 ]

6.  Secondary:   Correlation of SVR With Rapid Virological Response (RVR)   [ Time Frame: Up to 24 weeks after EOT (up to Week 96) ]

7.  Secondary:   Correlation of SVR With Early Virological Response (EVR)   [ Time Frame: Up to 24 weeks after EOT (up to Week 96) ]

8.  Secondary:   Predictive Power Values of Host-, Virus- and Treatment-related Factors and Virological Response   [ Time Frame: Week 4 and 12 ]

9.  Secondary:   Duration of Treatment in Participants With SVR by HCV Genotype   [ Time Frame: Up to Week 72 ]

10.  Secondary:   Cumulative PEG-IFN Alfa-2a Dose in Participants With SVR by HCV Genotype   [ Time Frame: Up to Week 72 ]

11.  Secondary:   Cumulative Ribavirin Dose in Participants With SVR by HCV Genotype   [ Time Frame: Up to Week 72 ]

12.  Secondary:   Percentage of Participants With Virological Response   [ Time Frame: 4 weeks after EOT (up to Week 76) ]


  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: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01392742     History of Changes
Other Study ID Numbers: ML25670
Study First Received: July 11, 2011
Results First Received: November 9, 2015
Last Updated: November 9, 2015
Health Authority: Bulgaria: Bulgarian Drug Agency