Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01447446
First received: October 4, 2011
Last updated: February 10, 2017
Last verified: December 2016
Results First Received: September 27, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Hepatitis C, Chronic
Interventions: Drug: Peg-IFN Alfa-2a
Drug: Peg-IFN Alfa-2b
Drug: Ribavirin
Drug: Boceprevir
Drug: Telaprevir

  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 4442 participants were enrolled in the study, one participant had double enrollment. Out of 4442 participants, analyses were restricted to only core population, which included 4100 participants.

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
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.

Participant Flow:   Overall Study
    Dual Therapy: Peg-IFN Alfa-2a + Ribavirin   Dual Therapy: Peg-IFN Alfa-2b + Ribavirin   Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin   Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin   Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin   Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
STARTED   2312 [1]   496   292   93   821   86 
COMPLETED   1590 [2]   331 [3]   192   60   610   54 
NOT COMPLETED   722   165   100   33   211   32 
Death                6                3                2                1                7                0 
Adverse Event                3                0                1                0                2                0 
Failure to Return/Consent Withdrawn                357                78                31                7                69                9 
Insuff. VR/TRT too Short to Expect VR                300                71                52                21                92                14 
Administrative/Other                34                9                10                2                33                4 
SVR12 Assessment                13                1                2                1                5                5 
New Treatment Started                8                2                1                0                2                0 
Reason not Specified                1                1                1                1                1                0 
[1] Started means participants who started treatment and included in core population.
[2] Completed means the participants who completed the 24- weeks of follow-up period.
[3] Insuff.=Insufficient VR= Virological response TRT.=Treatment SVR= Sustained Virological Response



  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.
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).

Reporting Groups
  Description
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Total Total of all reporting groups

Baseline Measures
   Dual Therapy: Peg-IFN Alfa-2a + Ribavirin   Dual Therapy: Peg-IFN Alfa-2b + Ribavirin   Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin   Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin   Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin   Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin   Total 
Overall Participants Analyzed 
[Units: Participants]
 2312   496   292   93   821   86   4100 
Age, Customized 
[Units: Participants]
             
Less Than or Equal to (<=) 45 Years   987   178   73   21   184   14   1457 
Greater (>) 45 years   1325   318   219   72   637   72   2643 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      910  39.4%      250  50.4%      108  37.0%      37  39.8%      331  40.3%      43  50.0%      1679  41.0% 
Male      1402  60.6%      246  49.6%      184  63.0%      56  60.2%      490  59.7%      43  50.0%      2421  59.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24)   [ Time Frame: 24 weeks after end of treatment (up to 118 weeks) ]

2.  Primary:   Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12)   [ Time Frame: 12 weeks after end of treatment (up to 118 weeks) ]

3.  Secondary:   Virological Response at Various on Treatment Time Points and End of Treatment (EOT)   [ Time Frame: Week 4, 12 and End of treatment (EOT) (up to 96 weeks) ]

4.  Secondary:   Virological Relapse After End of Treatment   [ Time Frame: Up to 24 weeks after EOT (up to 118 weeks) ]

5.  Secondary:   Virological Breakthrough   [ Time Frame: Up to EOT (up to 118 weeks) ]

6.  Secondary:   Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions   [ Time Frame: Up to first 12 weeks of treatment ]

7.  Secondary:   Percentage of Participants With Very Rapid Virological Response, Rapid Virological Response, Complete Early Virological Response and Partial Early Virological Response (pEVR) During First 12 Weeks   [ Time Frame: Up to 12 weeks ]

8.  Secondary:   Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR)   [ Time Frame: Up to 98 weeks ]

9.  Secondary:   Duration of Overall Treatment   [ Time Frame: Up to 118 weeks ]

10.  Secondary:   Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC)   [ Time Frame: Up to 118 weeks ]

11.  Secondary:   Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV)   [ Time Frame: Up to 72 weeks of treatment ]

12.  Secondary:   Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA)   [ Time Frame: Up to 72 weeks of treatment ]

13.  Secondary:   Percentage of Participants With Concomitant Medical Condition at Baseline   [ Time Frame: Baseline ]

14.  Secondary:   Percentage of Participants With Adverse Events (AE)   [ Time Frame: Up to 118 weeks ]


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



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01447446     History of Changes
Other Study ID Numbers: MV25599
Study First Received: October 4, 2011
Results First Received: September 27, 2016
Last Updated: February 10, 2017