Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01390844
First received: July 7, 2011
Last updated: May 20, 2016
Last verified: May 2016
Results First Received: May 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Drug: Boceprevir (BOC)
Drug: Placebo to boceprevir
Drug: Peginterferon alfa-2b (PEG)
Drug: Ribavirin (RBV)
Drug: Cross-Over Boceprevir Treatment

  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
Adult participants in an Asia Pacific population with chronic Hepatitis C (CHC) genotype 1 who have failed prior treatment with pegylated interferon and ribavirin (PR) were selected to participate in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 282 participants randomized and treated, 269 participants followed Good Clinical Practice (GCP); 13 participants did not follow GCP.

Reporting Groups
  Description
Boceprevir - Korea+Taiwan PegIntron (pegylated interferon alfa-2b) (PEG) + ribavirin (RBV) for 4 weeks followed by boceprevir (BOC) + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
Control - Korea+Taiwan PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
Boceprevir - India PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
Control - India PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.

Participant Flow for 2 periods

Period 1:   Treatment Phase
    Boceprevir - Korea+Taiwan     Control - Korea+Taiwan     Boceprevir - India     Control - India  
STARTED     133     65     57     27  
COMPLETED     93     37     26     8  
NOT COMPLETED     40     28     31     19  
Adverse Event                 12                 2                 3                 2  
Treatment Failure                 23                 25                 10                 13  
Non-Medical Reasons                 5                 1                 8                 1  
Non-GCP Compliant                 0                 0                 10                 3  

Period 2:   Follow-Up Phase
    Boceprevir - Korea+Taiwan     Control - Korea+Taiwan     Boceprevir - India     Control - India  
STARTED     93     37     26     8  
COMPLETED     92     36     25     8  
NOT COMPLETED     1     1     1     0  
Non-Medical Reasons                 1                 1                 1                 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.
All Participants Randomized

Reporting Groups
  Description
Boceprevir - Korea+Taiwan PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
Control - Korea+Taiwan PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
Boceprevir - India PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
Control - India PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
Total Total of all reporting groups

Baseline Measures
    Boceprevir - Korea+Taiwan     Control - Korea+Taiwan     Boceprevir - India     Control - India     Total  
Number of Participants  
[units: participants]
  133     65     57     27     282  
Age  
[units: Years]
Mean (Standard Deviation)
  54.0  (10.15)     52.4  (9.80)     47.9  (9.83)     45.2  (12.27)     51.6  (10.63)  
Gender  
[units: Participants]
         
Female     48     28     18     5     99  
Male     85     37     39     22     183  



  Outcome Measures
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1.  Primary:   Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population   [ Time Frame: Follow-up Week 24 ]

2.  Primary:   Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population   [ Time Frame: Follow-up Week 24 ]

3.  Secondary:   Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population   [ Time Frame: Follow-up Week 24 ]

4.  Secondary:   Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population   [ Time Frame: Follow-up Week 24 ]

5.  Secondary:   Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8   [ Time Frame: Treatment Week 8 ]

6.  Secondary:   Percentage of Participants in India Achieving EVR at Treatment Week 8   [ Time Frame: Treatment Week 8 ]

7.  Secondary:   Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan   [ Time Frame: Up to 96 weeks ]

8.  Secondary:   Percentage of Participants With an AE of Anemia in India   [ Time Frame: Up to 96 weeks ]

9.  Secondary:   Percentage of Participants With an AE of Neutropenia in Korea and Taiwan   [ Time Frame: Up to 96 weeks ]

10.  Secondary:   Percentage of Participants With an AE of Neutropenia in India   [ Time Frame: Up to 96 weeks ]


  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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01390844     History of Changes
Other Study ID Numbers: P07063
2007-005151-42 ( EudraCT Number )
3034-033 ( Other Identifier: Merck study number )
CTRI/2012/04/002540 ( Registry Identifier: CTRI )
Study First Received: July 7, 2011
Results First Received: May 20, 2016
Last Updated: May 20, 2016
Health Authority: India: Drugs Controller General of India