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Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074)

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ClinicalTrials.gov Identifier: NCT02133131
Recruitment Status : Completed
First Posted : May 7, 2014
Results First Posted : November 17, 2016
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hepatitis C
Interventions: Drug: Grazoprevir/Elbasvir FDC
Drug: Sofosbuvir

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The current interim disclosure covers data up to 12 weeks after completing study treatment. The cutoff date for this initial disclosure is 12-Feb-2015. GT3 participants have completed treatment but are ongoing in follow-up.

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
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.

Participant Flow:   Overall Study
    GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks   GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks   GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks   GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks   GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks   GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks   GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks
STARTED   31   30   20   21   15   14   12 
COMPLETED   26   25   19   15   0   0   0 
NOT COMPLETED   5   5   1   6   15   14   12 
Adverse Event                0                0                0                1                0                0                0 
Lost to Follow-up                1                0                0                1                0                0                0 
Status not recorded                4                5                1                4                0                0                0 
Ongoing in study                0                0                0                0                15                14                11 
Protocol Violation                0                0                0                0                0                0                1 



  Baseline Characteristics

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
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
Total Total of all reporting groups

Baseline Measures
   GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks   GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks   GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks   GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks   GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks   GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks   GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   30   20   21   15   14   12   143 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.1  (9.7)   51.2  (9.5)   55.7  (7.7)   56.8  (8.8)   51.3  (10.1)   42.2  (11.7)   55.3  (5.3)   52.3  (9.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
               
Female      11  35.5%      11  36.7%      7  35.0%      8  38.1%      4  26.7%      6  42.9%      2  16.7%      49  34.3% 
Male      20  64.5%      19  63.3%      13  65.0%      13  61.9%      11  73.3%      8  57.1%      10  83.3%      94  65.7% 


  Outcome Measures

1.  Primary:   Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12)   [ Time Frame: Up to 24 weeks ]

2.  Primary:   Number of Participants Experiencing at Least 1 Adverse Event (AE)   [ Time Frame: Up to Week 14 ]

3.  Primary:   Number of Participants Discontinuing Study Therapy Due to an AE   [ Time Frame: Up to Week 12 ]

4.  Secondary:   Percentage of Participants Achieving SVR 4 Weeks After Completing All Study Therapy (SVR4)   [ Time Frame: Up to 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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: ClinicalTrialDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02133131     History of Changes
Other Study ID Numbers: 5172-074
First Submitted: May 5, 2014
First Posted: May 7, 2014
Results First Submitted: September 27, 2016
Results First Posted: November 17, 2016
Last Update Posted: April 4, 2017