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Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05101AM3)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00708500
First received: June 27, 2008
Last updated: September 24, 2015
Last verified: September 2015
Results First Received: May 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Drug: Boceprevir (SCH 503034)
Biological: Pegylated interferon alfa-2b (SCH 54031)
Drug: Ribavirin (SCH 18908)
Drug: Boceprevir placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
154 participants who discontinued during the treatment phase (including those from lead in and/or boceprevir/placebo) entered the follow up phase

Reporting Groups
  Description
Placebo+PEG2b+RBV, x 44 Weeks Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Boceprevir+PEG2b+RBV, Response Guided Therapy

Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.

PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:

  • 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
  • 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.
Boceprevir+PEG2b+RBV, x 44 Weeks Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Participant Flow for 3 periods

Period 1:   Treatment (Tx): 4 WEEK LEAD-IN PERIOD
    Placebo+PEG2b+RBV, x 44 Weeks   Boceprevir+PEG2b+RBV, Response Guided Therapy   Boceprevir+PEG2b+RBV, x 44 Weeks
STARTED   80   162   162 
Treated With PEG2b + RBV   80   162   161 
COMPLETED   78   156   160 
NOT COMPLETED   2   6   2 
Adverse Event                1                3                1 
Subject withdrawal unrelated to Tx                1                0                0 
Subject withdrawal related to Tx                0                1                0 
Subject withdrew consent                0                2                0 
Randomized but not treated                0                0                1 

Period 2:   Tx: RECEIVING BOCEPREVIR/PLACEBO
    Placebo+PEG2b+RBV, x 44 Weeks   Boceprevir+PEG2b+RBV, Response Guided Therapy   Boceprevir+PEG2b+RBV, x 44 Weeks
STARTED   78   156   160 
COMPLETED   23   104   105 
NOT COMPLETED   55   52   55 
Adverse Event                1                10                19 
Treatment Failure                49                36                29 
Lost to Follow-up                0                1                0 
Subject withdrawal unrelated to Tx                3                1                4 
Subject withdrawal related to Tx                2                0                1 
Subject withdrew consent                0                2                1 
Non-compliance with protocol                0                1                1 
Administrative                0                1                0 

Period 3:   FOLLOWUP
    Placebo+PEG2b+RBV, x 44 Weeks   Boceprevir+PEG2b+RBV, Response Guided Therapy   Boceprevir+PEG2b+RBV, x 44 Weeks
STARTED   77   151   158 
COMPLETED   37   136   143 
NOT COMPLETED   40   15   15 
Adverse Event                0                1                0 
Lost to Follow-up                1                6                4 
Subject withdrawal unrelated to Tx                3                4                5 
Subject withdrew consent                31                4                5 
Non-compliance with protocol                5                0                1 



  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.
No text entered.

Reporting Groups
  Description
Placebo+PEG2b+RBV, x 44 Weeks Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Boceprevir+PEG2b+RBV, Response Guided Therapy

Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.

PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:

  • 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
  • 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.
Boceprevir+PEG2b+RBV, x 44 Weeks Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Total Total of all reporting groups

Baseline Measures
   Placebo+PEG2b+RBV, x 44 Weeks   Boceprevir+PEG2b+RBV, Response Guided Therapy   Boceprevir+PEG2b+RBV, x 44 Weeks   Total 
Overall Participants Analyzed 
[Units: Participants]
 80   162   161   403 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.9  (8.1)   52.9  (7.4)   52.3  (7.7)   52.7  (7.7) 
Gender 
[Units: Participants]
       
Female   22   64   49   135 
Male   58   98   112   268 


  Outcome Measures
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1.  Primary:   Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population.   [ Time Frame: At Follow-up Week 24 ]

2.  Secondary:   Sustained Virologic Response (SVR) Rate in the Modified Intent to Treat (mITT) Population.   [ Time Frame: At Follow-up Week 24 ]

3.  Secondary:   Number of Participants With Early Virologic Response.   [ Time Frame: At Week 2, 4, 8, or 12 ]

4.  Secondary:   Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.   [ Time Frame: At Follow-up Week 12 and at 72 weeks after randomization ]


  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
No text entered.


  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
e-mail: ClinicalTrialsDisclosure@merck.com


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00708500     History of Changes
Other Study ID Numbers: P05101
2007-005151-42
Study First Received: June 27, 2008
Results First Received: May 13, 2011
Last Updated: September 24, 2015
Health Authority: United States: Food and Drug Administration