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Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01544920
First received: February 28, 2012
Last updated: April 22, 2016
Last verified: April 2016
Results First Received: April 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Biological: peg-Interferon alfa-2a
Drug: Ribavirin
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm 1: Peg-IFN + RBV Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
Arm 2: BOC + Peg-IFN + RBV Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].

Participant Flow:   Overall Study
    Arm 1: Peg-IFN + RBV   Arm 2: BOC + Peg-IFN + RBV
STARTED   368   369 
COMPLETED   349   346 
NOT COMPLETED   19   23 
Adverse Event                0                3 
Death                0                1 
Lost to Follow-up                11                12 
Protocol Violation                0                2 
Physician Decision                4                1 
Withdrawal by Subject                4                4 



  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.
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Reporting Groups
  Description
Arm 1: Peg-IFN + RBV Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
Arm 2: BOC + Peg-IFN + RBV Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
Total Total of all reporting groups

Baseline Measures
   Arm 1: Peg-IFN + RBV   Arm 2: BOC + Peg-IFN + RBV   Total 
Overall Participants Analyzed 
[Units: Participants]
 368   369   737 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.9  (12.0)   42.4  (12.4)   43.1  (12.2) 
Gender 
[Units: Participants]
     
Female   167   148   315 
Male   201   221   422 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) 24 Weeks After Completing Study Treatment (SVR24)   [ Time Frame: Up to Week 74 ]

2.  Secondary:   Percentage of Participants Who Had Undetectable HCV RNA at Week 4 Achieving SVR24   [ Time Frame: Up to Week 48 ]


  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: NCT01544920     History of Changes
Other Study ID Numbers: P07755
2011-001345-32 ( EudraCT Number )
MK-3034-040 ( Other Identifier: Merck )
CTRI/2012/12/003200 ( Registry Identifier: CTRI )
PHRR131022-000133 ( Registry Identifier: PHRR )
Study First Received: February 28, 2012
Results First Received: April 22, 2016
Last Updated: April 22, 2016
Health Authority: United States: Food and Drug Administration