PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Virus (HCV)Treated With Pegasys (Peginterferon Alfa-2a)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01070550
First received: February 9, 2010
Last updated: May 9, 2016
Last verified: May 2016
Results First Received: May 9, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Hepatitis C, Chronic
Intervention: Drug: Peginterferon alfa-2a (Pegasys®)

  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
A total of 4680 participants were enrolled into the study conducted from June 2007 to July 2011 at 332 centers in 14 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Genotype 1 Eligible participants infected with hepatitis C virus (HCV) of Genotype 1 who received PEGASYS® (Pegylated Interferon [PEG-IFN]) alfa-2a plus ribavirin according to the standard of care and in line with summary of product characteristics (SPCs)/local labelling were observed for up to 72 weeks.
Genotype 2 Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labelling were observed for up to 72 weeks.
Genotype 3 Eligible participants infected with HCV of Genotype 3 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling were observed for up to 72 weeks.
Genotype 4 Eligible participants infected with HCV of Genotype 4 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling were observed for up to 72 weeks.
Genotype 5/6 Eligible participants infected with HCV of Genotype 5/6 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
Genotype Unknown Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.

Participant Flow:   Overall Study
    Genotype 1     Genotype 2     Genotype 3     Genotype 4     Genotype 5/6     Genotype Unknown  
STARTED     3356     316     744     201     21     42  
COMPLETED     2071     254     528     124     20     35  
NOT COMPLETED     1285     62     216     77     1     7  
Adverse Event                 43                 1                 3                 0                 0                 0  
Death                 20                 4                 3                 0                 0                 0  
Not meeting inclusion/exclusion criteria                 2                 1                 1                 0                 0                 0  
Early termination                 3                 0                 0                 0                 0                 0  
Failed to return                 450                 33                 144                 40                 1                 2  
Incomplete treatment                 2                 0                 0                 0                 0                 0  
Lab test not done                 22                 3                 4                 1                 0                 1  
Lack of Efficacy                 65                 1                 5                 5                 0                 1  
Miscellaneous                 12                 2                 3                 1                 0                 0  
New treatment started                 3                 1                 0                 2                 0                 0  
Non-responders                 493                 4                 21                 20                 0                 2  
Not categorized                 33                 2                 6                 1                 0                 1  
Protocol Violation                 15                 1                 1                 1                 0                 0  
Relapse                 44                 5                 14                 4                 0                 0  
Result not available                 3                 1                 3                 0                 0                 0  
Screen failure                 1                 0                 0                 0                 0                 0  
Sponsor decision                 1                 0                 0                 0                 0                 0  
Treatment duration shortened                 1                 0                 0                 0                 0                 0  
Treatment interrupted                 7                 0                 1                 1                 0                 0  
Treatment not started                 14                 2                 4                 0                 0                 0  
Treatment restarted                 0                 1                 0                 0                 0                 0  
Treatment stopped                 3                 0                 0                 0                 0                 0  
Treatment unavailable                 1                 0                 0                 0                 0                 0  
Treatment was stopped early                 7                 0                 0                 0                 0                 0  
Unknown                 5                 0                 0                 1                 0                 0  
Withdrawal by Subject                 35                 0                 3                 0                 0                 0  



  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.
All enrolled population included every participant for whom there was any data available in the PROPHESYS 1 database.

Reporting Groups
  Description
Genotype 1 Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
Genotype 2 Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
Genotype 3 Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
Genotype 4 Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
Genotype 5/6 Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
Genotype Unknown Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
Total Total of all reporting groups

Baseline Measures
    Genotype 1     Genotype 2     Genotype 3     Genotype 4     Genotype 5/6     Genotype Unknown     Total  
Number of Participants  
[units: participants]
  3356     316     744     201     21     42     4680  
Age  
[units: Years]
Mean (Standard Deviation)
  47.1  (11.87)     52.0  (11.74)     40.8  (10.25)     43.1  (9.87)     52.5  (11.81)     44.9  (10.62)     46.3  (11.86)  
Gender, Customized  
[units: Participants]
             
Female     1610     155     243     54     4     16     2082  
Male     1746     161     501     147     17     25     2597  
Unknown     0     0     0     0     0     1     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population   [ Time Frame: At 24 weeks after EOT ]

2.  Primary:   Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population   [ Time Frame: At 24 weeks after EOT ]

3.  Primary:   Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population   [ Time Frame: At 24 weeks after EOT ]

4.  Primary:   Percentage of Participants With Modified Sustained Virological Response by Genotype in Per-Protocol Population   [ Time Frame: At 24 weeks after EOT ]

5.  Primary:   Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population   [ Time Frame: At 24 weeks after EOT ]

6.  Primary:   Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population   [ Time Frame: At 24 weeks after EOT ]

7.  Secondary:   Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time   [ Time Frame: At Week 2, Week 4, and Week 12, EOT, and 12 weeks after EOT ]

8.  Secondary:   Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time   [ Time Frame: At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT ]

9.  Secondary:   Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time   [ Time Frame: At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT ]

10.  Secondary:   Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time   [ Time Frame: At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT ]

11.  Secondary:   Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12   [ Time Frame: At Week 2, Week 4, and Week 12 ]

12.  Secondary:   Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12   [ Time Frame: Week 2, Week 4, and Week 12 ]

13.  Secondary:   Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12   [ Time Frame: Week 2, Week 4, and Week 12 ]

14.  Secondary:   Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12   [ Time Frame: Week 2, Week 4, and Week 12 ]

15.  Secondary:   Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12   [ Time Frame: Week 4 and Week 12 ]

16.  Secondary:   Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12   [ Time Frame: At Week 4 and Week 12 ]

17.  Secondary:   Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment   [ Time Frame: At 12 Weeks after EOT ]

18.  Secondary:   Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment   [ Time Frame: At 12 weeks after EOT ]

19.  Secondary:   Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment   [ Time Frame: At 24 weeks after EOT ]

20.  Secondary:   Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment   [ Time Frame: At 24 weeks after EOT ]

21.  Secondary:   Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population   [ Time Frame: At 24 weeks after EOT ]

22.  Secondary:   Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population   [ Time Frame: At 24 weeks after EOT ]


  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 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: Roche Trial Information Hotline
Organization: Hoffmann-La Roche AG
phone: +41 61 6878333
e-mail: global.trial_information@roche.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01070550     History of Changes
Other Study ID Numbers: MV21012
Study First Received: February 9, 2010
Results First Received: May 9, 2016
Last Updated: May 9, 2016
Health Authority: Canada: Canadian Institutes of Health Research