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A Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00998985
First received: October 20, 2009
Last updated: February 3, 2016
Last verified: January 2016
Results First Received: February 3, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hepatitis C
Interventions: Drug: Grazoprevir
Drug: Placebo

  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
One of the originally planned treatment groups (50 mg Grazoprevir - GT3) was not conducted because other results indicated that further evaluation of 50 mg Grazoprevir in GT3 participants was not necessary. It is therefore not included in the Participant Flow.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
400 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
600 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
800 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
400 mg Grazoprevir - GT3 GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
600 mg Grazoprevir - GT3 GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
800 mg Grazoprevir - GT3 GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
200 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
100 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
50 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
200 mg Grazoprevir - GT3 GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
100 mg Grazoprevir - GT3 GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
30 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
10 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
Placebo for Grazoprevir - GT1 and GT3 GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days

Participant Flow:   Overall Study
    400 mg Grazoprevir - GT1   600 mg Grazoprevir - GT1   800 mg Grazoprevir - GT1   400 mg Grazoprevir - GT3   600 mg Grazoprevir - GT3   800 mg Grazoprevir - GT3   200 mg Grazoprevir - GT1   100 mg Grazoprevir - GT1   50 mg Grazoprevir - GT1   200 mg Grazoprevir - GT3   100 mg Grazoprevir - GT3   30 mg Grazoprevir - GT1   10 mg Grazoprevir - GT1   Placebo for Grazoprevir - GT1 and GT3
STARTED   5   5   15   5   5   5   5   5   6   5   5   5   5   15 
COMPLETED   5   5   15   5   5   4   5   5   5   5   5   5   5   15 
NOT COMPLETED   0   0   0   0   0   1   0   0   1   0   0   0   0   0 
Withdrawal by Subject                0                0                0                0                0                0                0                0                1                0                0                0                0                0 
Protocol Violation                0                0                0                0                0                1                0                0                0                0                0                0                0                0 



  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.
All randomized participants

Reporting Groups
  Description
400 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
600 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
800 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
400 mg Grazoprevir - GT3 GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
600 mg Grazoprevir - GT3 GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
800 mg Grazoprevir - GT3 GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
200 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
100 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
50 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
200 mg Grazoprevir - GT3 GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
100 mg Grazoprevir - GT3 GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
30 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
10 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
Placebo for Grazoprevir - GT1 and GT3 GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
Total Total of all reporting groups

Baseline Measures
   400 mg Grazoprevir - GT1   600 mg Grazoprevir - GT1   800 mg Grazoprevir - GT1   400 mg Grazoprevir - GT3   600 mg Grazoprevir - GT3   800 mg Grazoprevir - GT3   200 mg Grazoprevir - GT1   100 mg Grazoprevir - GT1   50 mg Grazoprevir - GT1   200 mg Grazoprevir - GT3   100 mg Grazoprevir - GT3   30 mg Grazoprevir - GT1   10 mg Grazoprevir - GT1   Placebo for Grazoprevir - GT1 and GT3   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   5   15   5   5   5   5   5   6   5   5   5   5   15   91 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.4  (12.8)   47.2  (12.2)   46.7  (9.7)   42.8  (14.4)   38.0  (13.1)   46.2  (10.8)   51.0  (16.2)   48.4  (5.9)   36.8  (6.0)   40.0  (10.2)   31.4  (6.3)   55.8  (5.4)   48.4  (13.1)   45.6  (11.5)   44.7  (11.5) 
Gender 
[Units: Participants]
                             
Female   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0 
Male   5   5   15   5   5   5   5   5   6   5   5   5   5   15   91 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Clinical and Laboratory Adverse Events (AEs)   [ Time Frame: All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days) ]

2.  Secondary:   Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7   [ Time Frame: Day 7 at the following time points: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose ]

3.  Secondary:   24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7   [ Time Frame: Day 7 at 24 hours post-dose ]

4.  Secondary:   Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT1 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo   [ Time Frame: Baseline and up to approximately 2 months ]

5.  Secondary:   Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT3 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo   [ Time Frame: Baseline and up to approximately 2 months ]


  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: NCT00998985     History of Changes
Other Study ID Numbers: 5172-004
2009_678 ( Other Identifier: Merck )
2009-015563-13 ( EudraCT Number )
Study First Received: October 20, 2009
Results First Received: February 3, 2016
Last Updated: February 3, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices