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: December 4, 2013
Last verified: December 2013
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  
Number of Participants  
[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
  Show All Outcome Measures

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


  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.


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.  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
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: 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: December 4, 2013
Health Authority: United States: Food and Drug Administration