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Safety and Efficacy of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 (Study P05216AM2) (COMPLETED) (SPRINT-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00705432
First received: June 24, 2008
Last updated: October 16, 2015
Last verified: October 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: Biological: Peginterferon alfa-2b (PEG)
Drug: Ribavirin (RBV)
Drug: Placebo
Drug: Boceprevir

  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
1472 participants were enrolled in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
373 participants were screened but not randomized. 1099 participants were randomized. Only 1097 received at least one dose of PegIntron (PEG) + Ribavirin (RBV) (lead-in treatment).

Reporting Groups
  Description
Cohort I - 1. Placebo + PEG + RBV Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)

Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Cohort II - 1. Placebo + PEG + RBV Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)

Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Participant Flow for 2 periods

Period 1:   Treatment Period
    Cohort I - 1. Placebo + PEG + RBV   Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)   Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks   Cohort II - 1. Placebo + PEG + RBV   Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)   Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks
STARTED   311   316   311   52   52   55 
STARTED BOCEPREVIR/PLACEBO   297   303   299   47   47   55 
COMPLETED   148   205   190   11   24   25 
NOT COMPLETED   163   111   121   41   28   30 
Adverse Event                45                37                51                12                8                9 
Treatment failure                92                42                33                25                13                14 
Non medical reason                26                32                37                4                7                7 

Period 2:   Follow-up Period (Upto Week 72)
    Cohort I - 1. Placebo + PEG + RBV   Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)   Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks   Cohort II - 1. Placebo + PEG + RBV   Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)   Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks
STARTED   278   295   291   42   44   53 
COMPLETED   207   252   266   28   38   46 
NOT COMPLETED   71   43   25   14   6   7 
Adverse Event                2                1                1                0                0                0 
Non medical reason                69                42                24                14                6                7 



  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
Cohort I - 1. Placebo + PEG + RBV Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)

Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Cohort II - 1. Placebo + PEG + RBV Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)

Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Total Total of all reporting groups

Baseline Measures
   Cohort I - 1. Placebo + PEG + RBV   Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)   Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks   Cohort II - 1. Placebo + PEG + RBV   Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)   Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks   Total 
Overall Participants Analyzed 
[Units: Participants]
 311   316   311   52   52   55   1097 
Age, Customized 
[Units: Participants]
             
<40 years   51   45   49   6   3   4   158 
>= 40 and <65 years   246   261   255   45   47   51   905 
>=65 years   14   10   7   1   2   0   34 
Gender 
[Units: Participants]
             
Female   140   116   123   17   23   22   441 
Male   171   200   188   35   29   33   656 


  Outcome Measures
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1.  Primary:   Sustained Virologic Response (SVR) Rate   [ Time Frame: At Follow-up Week (FW) 24 ]

2.  Secondary:   Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo)   [ Time Frame: At FW 24 ]

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

4.  Secondary:   Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20)   [ Time Frame: At Treatment Week 2, 4, 8, 12, 16, or 20 ]

5.  Secondary:   Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR   [ Time Frame: At Treatment Week 4, 8, 12, 16, 20 ]


  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.
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: NCT00705432     History of Changes
Obsolete Identifiers: NCT00795431
Other Study ID Numbers: P05216
EUDRACT # 2007-005508-42
Study First Received: June 24, 2008
Results First Received: May 13, 2011
Last Updated: October 16, 2015
Health Authority: United States: Food and Drug Administration