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: August 12, 2014
Last verified: August 2014
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
  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
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
  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.
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  
Number of Participants  
[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
  Show All Outcome Measures

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


No publications provided by Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:

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: August 12, 2014
Health Authority: United States: Food and Drug Administration