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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 : October 3, 2018
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
Enrollment 143

Recruitment Details 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  
Arm/Group Title 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
Hide Arm/Group Description HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks. HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks. HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks. HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks. HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks. HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks. HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
Period Title: Overall Study
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
Reason Not Completed
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
Arm/Group Title 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
Hide Arm/Group Description HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks. HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks. HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks. HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks. HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks. HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks. HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 31 30 20 21 15 14 12 143
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 30 participants 20 participants 21 participants 15 participants 14 participants 12 participants 143 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 30 participants 20 participants 21 participants 15 participants 14 participants 12 participants 143 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%
1.Primary Outcome
Title Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12)
Hide Description The percentage of participants achieving SVR12, defined as HCV ribonucleic acid (RNA) <15 IU/mL 12 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.
Time Frame Up to 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol (PP) population includes all randomized and treated participants who did not have protocol deviations that may substantially affect the results of the primary and secondary endpoints.
Arm/Group Title 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
Hide Arm/Group Description:
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
Overall Number of Participants Analyzed 30 28 20 19 15 14 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
33.3
(17.3 to 52.8)
89.3
(71.8 to 97.7)
80.0
(56.3 to 94.3)
89.5
(66.9 to 98.7)
93.3
(68.1 to 99.8)
100.0
(76.8 to 100.00)
90.9
(58.7 to 99.8)
2.Primary Outcome
Title Number of Participants Experiencing at Least 1 Adverse Event (AE)
Hide Description An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Up to Week 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The All Participants as Treated (APaT) population consists of all participants who received ≥1 dose of study drug.
Arm/Group Title 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
Hide Arm/Group Description:
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
Overall Number of Participants Analyzed 31 30 20 21 15 14 12
Measure Type: Number
Unit of Measure: Number of participants
5 7 7 4 4 3 3
3.Primary Outcome
Title Number of Participants Discontinuing Study Therapy Due to an AE
Hide Description An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Up to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The APaT population consists of all participants who received ≥1 dose of study drug.
Arm/Group Title 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
Hide Arm/Group Description:
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
Overall Number of Participants Analyzed 31 30 20 21 15 14 12
Measure Type: Number
Unit of Measure: Number of participants
0 0 0 1 0 0 0
4.Secondary Outcome
Title Percentage of Participants Achieving SVR 4 Weeks After Completing All Study Therapy (SVR4)
Hide Description The percentage of participants achieving SVR4, defined as HCV ribonucleic acid (RNA) <15 IU/mL 4 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.
Time Frame Up to 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis of SVR4 is ongoing and results will be indicated in a future report.
Arm/Group Title 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
Hide Arm/Group Description:
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 14 weeks
Adverse Event Reporting Description An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
 
Arm/Group Title 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
Hide Arm/Group Description HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks. HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks. HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks. HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks. HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks. HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks. HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      0/30 (0.00%)      1/20 (5.00%)      1/21 (4.76%)      1/15 (6.67%)      0/14 (0.00%)      1/12 (8.33%)    
Blood and lymphatic system disorders               
Haemorrhagic anaemia  1  0/31 (0.00%)  0 0/30 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/12 (0.00%)  0
Hepatobiliary disorders               
Hepatic mass  1  0/31 (0.00%)  0 0/30 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 1/12 (8.33%)  1
Infections and infestations               
Lobar pneumonia  1  0/31 (0.00%)  0 0/30 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 0/12 (0.00%)  0
Pneumonia  1  0/31 (0.00%)  0 0/30 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 0/12 (0.00%)  0
Pyelonephritis  1  0/31 (0.00%)  0 0/30 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/12 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Diffuse large B-cell lymphoma  1  0/31 (0.00%)  0 0/30 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v. 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/31 (6.45%)      2/30 (6.67%)      2/20 (10.00%)      4/21 (19.05%)      4/15 (26.67%)      3/14 (21.43%)      3/12 (25.00%)    
Ear and labyrinth disorders               
Vertigo  1  0/31 (0.00%)  0 0/30 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 0/12 (0.00%)  0
Gastrointestinal disorders               
Constipation  1  0/31 (0.00%)  0 0/30 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 0/12 (0.00%)  0
Diarrhea  1  1/31 (3.23%)  1 0/30 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 1/12 (8.33%)  1
Nausea  1  0/31 (0.00%)  0 1/30 (3.33%)  1 0/20 (0.00%)  0 1/21 (4.76%)  1 0/15 (0.00%)  0 1/14 (7.14%)  1 1/12 (8.33%)  1
General disorders               
Fatigue  1  1/31 (3.23%)  1 1/30 (3.33%)  1 0/20 (0.00%)  0 0/21 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/12 (8.33%)  1
Infections and infestations               
Urinary tract infection  1  0/31 (0.00%)  0 0/30 (0.00%)  0 0/20 (0.00%)  0 2/21 (9.52%)  2 0/15 (0.00%)  0 0/14 (0.00%)  0 0/12 (0.00%)  0
Injury, poisoning and procedural complications               
Accidental overdose  1  0/31 (0.00%)  0 0/30 (0.00%)  0 1/20 (5.00%)  1 0/21 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 0/12 (0.00%)  0
Nervous system disorders               
Dizziness  1  0/31 (0.00%)  0 0/30 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 0/12 (0.00%)  0
Dysgeusia  1  0/31 (0.00%)  0 0/30 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 0/12 (0.00%)  0
Headache  1  1/31 (3.23%)  1 0/30 (0.00%)  0 1/20 (5.00%)  1 2/21 (9.52%)  2 1/15 (6.67%)  1 0/14 (0.00%)  0 1/12 (8.33%)  1
Renal and urinary disorders               
Haematuria  1  0/31 (0.00%)  0 0/30 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders               
Pruritis  1  0/31 (0.00%)  0 0/30 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v. 16.0
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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
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: October 3, 2018