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PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01066819
First received: February 9, 2010
Last updated: June 27, 2016
Last verified: June 2016
Results First Received: May 9, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Hepatitis C, Chronic
Interventions: Drug: Peginterferon alfa-2a [Pegasys]
Drug: Peginterferon alfa-2b [PegIntron®]

  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
A total of 1656 participants were enrolled in this study conducted from January 2008 to August 2011 at 111 centres in United States.

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 (G1) Eligible participants with serologically proven Chronic hepatitis C (CHC) (Genotype 1) who received Pegylated Interferon (PEG-IFN) alfa-2a (PEGASYS®) or PEG-IFN alfa-2b (PegIntron®) plus ribavirin for up to 48 weeks according to the standard of care and in line with summaries of product characteristics (SPCs)/local labeling were observed.
Genotype 2 (G2) Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
Genotype 3 (G3) Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
Genotype 4 (G4) Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
Genotype 5/6 (G5/6) Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
Genotype Unknown (UNK) Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.

Participant Flow:   Overall Study
    Genotype 1 (G1)     Genotype 2 (G2)     Genotype 3 (G3)     Genotype 4 (G4)     Genotype 5/6 (G5/6)     Genotype Unknown (UNK)  
STARTED     1006     348     257     25     7     13  
COMPLETED     317     177     111     8     3     7  
NOT COMPLETED     689     171     146     17     4     6  
Adverse Event                 18                 1                 6                 0                 0                 0  
Death                 5                 0                 1                 0                 0                 0  
Lack of Efficacy                 22                 1                 2                 1                 0                 0  
Physician Decision                 6                 2                 3                 0                 0                 0  
Protocol Violation                 12                 6                 0                 0                 0                 0  
Withdrawal by Subject                 29                 11                 6                 0                 0                 0  
Administrative                 6                 4                 2                 0                 0                 0  
Not met inclusion/exclusion criteria                 1                 0                 0                 0                 0                 0  
Early termination                 2                 0                 0                 0                 0                 0  
Failed to return                 298                 107                 68                 7                 2                 3  
Lab test not done                 9                 0                 2                 1                 0                 0  
Miscellaneous                 28                 10                 18                 1                 0                 0  
Non responders                 123                 2                 7                 2                 0                 1  
Not categorised                 9                 2                 6                 1                 0                 0  
Relapse                 16                 4                 3                 0                 0                 0  
Results not available                 1                 0                 0                 0                 0                 0  
Screen failure                 1                 0                 0                 0                 0                 0  
Spontaneous cure                 1                 0                 0                 0                 0                 0  
Treatment never started                 85                 19                 19                 3                 2                 2  
Treatment stopped                 12                 1                 2                 1                 0                 0  
Unknown                 5                 1                 1                 0                 0                 0  



  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.
The All Patient Enrolled Population included every participant of whom there was any data in the PROPHESYS database.

Reporting Groups
  Description
Genotype 1 (G1) Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
Genotype 2 (G2) Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
Genotype 3 (G3) Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
Genotype 4 (G4) Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
Genotype 5/6 (G5/6) Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
Genotype Unknown (UNK) Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
Total Total of all reporting groups

Baseline Measures
    Genotype 1 (G1)     Genotype 2 (G2)     Genotype 3 (G3)     Genotype 4 (G4)     Genotype 5/6 (G5/6)     Genotype Unknown (UNK)     Total  
Number of Participants  
[units: participants]
  1006     348     257     25     7     13     1656  
Age  
[units: years]
Mean (Standard Deviation)
  48.4  (9.68)     49.7  (9.74)     46.9  (9.41)     46.4  (10.59)     53.3  (10.48)     45.6  (10.72)     48.4  (9.71)  
Gender  
[units: participants]
             
Female     419     148     110     5     3     7     692  
Male     587     200     147     20     4     6     964  



  Outcome Measures
  Show All Outcome Measures

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

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

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

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

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

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

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

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

11.  Secondary:   Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid 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-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12   [ Time Frame: At Week 2, Week 4 and Week 12 ]

13.  Secondary:   Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12   [ Time Frame: At Week 2, Week 4 and Week 12 ]

14.  Secondary:   Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per-Protocol Population at Week 2, Week 4 and Week 12   [ Time Frame: At Week 2, Week 4 and Week 12 ]

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

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

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

18.  Secondary:   Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12   [ Time Frame: During first 12 weeks of treatment ]

19.  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 ]

20.  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: 24 weeks after EOT ]

21.  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 ]

22.  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 ]


  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: Roche Trial Information Hotline
Organization: F. 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: NCT01066819     History of Changes
Other Study ID Numbers: MV21542
Study First Received: February 9, 2010
Results First Received: May 9, 2016
Last Updated: June 27, 2016
Health Authority: United States: Institutional Review Board