Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)

This study has been terminated.
(Preliminary results of MK-5172 PN003 (NCT01353911) suggested a possible dose relationship to elevated transaminase levels in treatment with grazoprevir.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01440595
First received: September 22, 2011
Last updated: February 3, 2016
Last verified: December 2015
Results First Received: February 3, 2016  
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: Grazoprevir
Drug: Placebo to Grazoprevir
Drug: Peginterferon alfa-2b (Peg-IFN)
Drug: Ribavirin (RBV)

  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
No participants were randomized to the Grazoprevir 800 mg + Peg-IFN + RBV arm.

Reporting Groups
  Description
Grazoprevir 200 mg + Peg-IFN + RBV Grazoprevir 200 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
Grazoprevir 400 mg + Peg-IFN + RBV Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
Placebo + Peg-IFN + RBV Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.

Participant Flow:   Overall Study
    Grazoprevir 200 mg + Peg-IFN + RBV     Grazoprevir 400 mg + Peg-IFN + RBV     Placebo + Peg-IFN + RBV  
STARTED     1     3     1  
COMPLETED     0     0     0  
NOT COMPLETED     1     3     1  
Lost to Follow-up                 0                 1                 0  
Study terminated by sponsor.                 1                 2                 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.
Five participants were randomized as indicated in the Participant Flow Module, but only 3 participants were treated. Baseline Characteristics are presented only for treated participants.

Reporting Groups
  Description
Grazoprevir 400 mg + Peg-IFN + RBV Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
Placebo + Peg-IFN + RBV Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Grazoprevir 400 mg + Peg-IFN + RBV     Placebo + Peg-IFN + RBV     Total  
Number of Participants  
[units: participants]
  2     1     3  
Age  
[units: years]
Mean (Standard Deviation)
  40.5  (7.8)     51.0  (0.0)     44.0  (8.2)  
Gender  
[units: Participants]
     
Female     1     1     2  
Male     1     0     1  



  Outcome Measures
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1.  Primary:   Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms   [ Time Frame: Week 12 ]

2.  Secondary:   Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA)   [ Time Frame: Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm ]

3.  Secondary:   Number of Participants Achieving Rapid Viral Response (RVR)   [ Time Frame: Week 4 ]

4.  Secondary:   Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12)   [ Time Frame: Week 24 for Grazoprevir treatment arms, Week 36 for Placebo arm ]

5.  Secondary:   Number of Participants Achieving Sustained Viral Response 24 Weeks After Completion of Therapy (SVR24)   [ Time Frame: Week 36 for Grazoprevir treatment arms, Week 48 for Placebo arm ]

6.  Secondary:   Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm   [ Time Frame: Week 12 ]

7.  Secondary:   Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm   [ Time Frame: Week 24 ]


  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.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01440595     History of Changes
Other Study ID Numbers: 5172-012
2011-003299-36 ( EudraCT Number )
Study First Received: September 22, 2011
Results First Received: February 3, 2016
Last Updated: February 3, 2016
Health Authority: United States: Food and Drug Administration