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Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic Hepatitis C Virus (HCV) Genotype 3 (GT3) Infection (MK-5172-083)

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ClinicalTrials.gov Identifier: NCT02601573
Recruitment Status : Completed
First Posted : November 10, 2015
Results First Posted : November 13, 2017
Last Update Posted : August 13, 2019
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
Drug: Elbasvir
Drug: Ribavirin
Drug: Sofosbuvir
Enrollment 101
Recruitment Details Adult participants infected with HCV GT3 were enrolled at 14 study centers in the United Kingdom.
Pre-assignment Details A total of 101 participants were randomized, including 1 participant who did not meet inclusion criteria and who should have been considered a screen failure; this participant was not treated with study drug. A total of 100 participants were treated.
Arm/Group Title Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
Hide Arm/Group Description Treatment-naïve (TN) Hepatitis C virus (HCV) genotype 3 (GT3) participants took 1 fixed-dose combination (FDC) tablet containing elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg and 1 tablet containing sofosbuvir (SOF) 400 mg once daily (q.d.) with ribavirin (RBV) (200 mg capsules; weight-based dosing) twice daily (b.i.d.) for 8 weeks. TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks. Treatment-experienced (TE) HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks. TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks. TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
Period Title: Overall Study
Started 23 [1] 24 [1] 17 [1] 18 [1] 18 [1]
Completed 23 20 16 17 16
Not Completed 0 4 1 1 2
Reason Not Completed
Lost to Follow-up             0             3             1             0             2
Withdrawal by Subject             0             1             0             1             0
[1]
Number randomized and treated.
Arm/Group Title Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks Total
Hide Arm/Group Description TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks. TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks. TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks. TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks. TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks. Total of all reporting groups
Overall Number of Baseline Participants 23 24 17 18 18 100
Hide Baseline Analysis Population Description
The Baseline Analysis population includes only the 100 participants who were both randomized and treated.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 24 participants 17 participants 18 participants 18 participants 100 participants
52.5  (9.0) 48.1  (9.3) 58.6  (6.1) 56.1  (8.4) 53.8  (6.4) 53.4  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 24 participants 17 participants 18 participants 18 participants 100 participants
Female
10
  43.5%
7
  29.2%
6
  35.3%
6
  33.3%
3
  16.7%
32
  32.0%
Male
13
  56.5%
17
  70.8%
11
  64.7%
12
  66.7%
15
  83.3%
68
  68.0%
1.Primary Outcome
Title Percentage of Participants Achieving SVR12 (Sustained Virologic Response 12 Weeks After the End of All Study Therapy)
Hide Description The percentage of participants achieving SVR12 (i.e., HCV ribnonucleic acid [RNA] < Lower Limit of Quantification [LLOQ] 12 weeks after completing study treatment) was determined. Plasma HCV RNA levels were determined with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.
Time Frame Up to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, were not lost to follow-up for reasons unrelated to study treatment, and had SVR12 data available are included.
Arm/Group Title Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
Hide Arm/Group Description:
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
Overall Number of Participants Analyzed 23 23 17 17 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
91.3
(72.0 to 98.9)
100.0
(85.2 to 100.0)
100.0
(80.5 to 100.0)
100.0
(80.5 to 100.0)
94.4
(72.7 to 99.9)
2.Primary Outcome
Title Percentage of Participants Experiencing an 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 18 weeks (up to 2 weeks after completion of study treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug are included.
Arm/Group Title Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
Hide Arm/Group Description:
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
Overall Number of Participants Analyzed 23 24 17 18 18
Measure Type: Number
Unit of Measure: Percentage of Participants
87.0 87.5 82.4 94.4 94.4
3.Primary Outcome
Title Percentage of Participants Discontinuing From 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 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug are included.
Arm/Group Title Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
Hide Arm/Group Description:
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
Overall Number of Participants Analyzed 23 24 17 18 18
Measure Type: Number
Unit of Measure: Percentage of Participants
0.0 0.0 0.0 0.0 5.6
4.Secondary Outcome
Title Percentage of Participants Achieving SVR24 (Sustained Virologic Response 24 Weeks After the End of All Study Therapy)
Hide Description The percentage of participants achieving SVR24 (i.e., HCV RNA < LLOQ 24 weeks after completing study treatment) was determined. Plasma HCV RNA levels were determined with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.
Time Frame Up to Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, were not lost to follow-up for reasons unrelated to study treatment, and had SVR24 data available are included.
Arm/Group Title Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
Hide Arm/Group Description:
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.
TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
Overall Number of Participants Analyzed 23 21 16 17 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
91.3
(72.0 to 98.9)
100.0
(83.9 to 100.0)
100.0
(79.4 to 100.0)
100.0
(80.5 to 100.0)
93.8
(69.8 to 99.8)
Time Frame Up to 40 weeks
Adverse Event Reporting Description All participants who received at least 1 dose of study drug are included.
 
Arm/Group Title Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
Hide Arm/Group Description TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks. TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks. TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks. TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks. TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
All-Cause Mortality
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      0/24 (0.00%)      2/17 (11.76%)      3/18 (16.67%)      1/18 (5.56%)    
General disorders           
Chest pain  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Infections and infestations           
Cellulitis  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Lung infection  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  2 0/18 (0.00%)  0 0/18 (0.00%)  0
Injury, poisoning and procedural complications           
Contusion  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Toxicity to various agents  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Wrist fracture  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Investigations           
Creatinine renal clearance decreased  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Hepatocellular carcinoma  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Pulmonary embolism  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/23 (91.30%)      21/24 (87.50%)      16/17 (94.12%)      17/18 (94.44%)      17/18 (94.44%)    
Cardiac disorders           
Palpitations  1  2/23 (8.70%)  2 0/24 (0.00%)  0 1/17 (5.88%)  1 1/18 (5.56%)  1 0/18 (0.00%)  0
Ear and labyrinth disorders           
Ear pain  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 1/18 (5.56%)  1 0/18 (0.00%)  0
Hypoacusis  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Eye disorders           
Dry eye  1  1/23 (4.35%)  1 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Lacrimation increased  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Myopia  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Vision blurred  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Visual impairment  1  0/23 (0.00%)  0 1/24 (4.17%)  1 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Gastrointestinal disorders           
Abdominal discomfort  1  2/23 (8.70%)  2 0/24 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Abdominal distension  1  0/23 (0.00%)  0 0/24 (0.00%)  0 3/17 (17.65%)  3 1/18 (5.56%)  2 0/18 (0.00%)  0
Abdominal pain  1  0/23 (0.00%)  0 2/24 (8.33%)  2 1/17 (5.88%)  1 4/18 (22.22%)  4 1/18 (5.56%)  1
Abdominal pain lower  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Abdominal pain upper  1  1/23 (4.35%)  1 2/24 (8.33%)  2 1/17 (5.88%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1
Ascites  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Constipation  1  1/23 (4.35%)  1 3/24 (12.50%)  3 1/17 (5.88%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1
Diarrhoea  1  1/23 (4.35%)  1 3/24 (12.50%)  4 3/17 (17.65%)  3 2/18 (11.11%)  2 3/18 (16.67%)  3
Dry mouth  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1
Dyspepsia  1  0/23 (0.00%)  0 1/24 (4.17%)  1 1/17 (5.88%)  1 1/18 (5.56%)  1 1/18 (5.56%)  1
Flatulence  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Gastrooesophageal reflux disease  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Haemorrhoids  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Lip dry  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Mouth ulceration  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  2 0/18 (0.00%)  0 0/18 (0.00%)  0
Nausea  1  4/23 (17.39%)  4 3/24 (12.50%)  3 3/17 (17.65%)  3 6/18 (33.33%)  7 3/18 (16.67%)  3
Oesophagitis  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Toothache  1  1/23 (4.35%)  1 1/24 (4.17%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Vomiting  1  0/23 (0.00%)  0 3/24 (12.50%)  3 1/17 (5.88%)  1 1/18 (5.56%)  1 1/18 (5.56%)  1
General disorders           
Chills  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 2/18 (11.11%)  2 1/18 (5.56%)  1
Fatigue  1  6/23 (26.09%)  6 8/24 (33.33%)  10 6/17 (35.29%)  6 10/18 (55.56%)  10 6/18 (33.33%)  6
Feeling hot  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Influenza like illness  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 2/18 (11.11%)  2
Oedema peripheral  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Pain  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Pyrexia  1  0/23 (0.00%)  0 2/24 (8.33%)  2 1/17 (5.88%)  1 1/18 (5.56%)  2 1/18 (5.56%)  1
Hepatobiliary disorders           
Biliary colic  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Jaundice  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 2/18 (11.11%)  2 0/18 (0.00%)  0
Immune system disorders           
Hypersensitivity  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Seasonal allergy  1  1/23 (4.35%)  1 1/24 (4.17%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Infections and infestations           
Cellulitis  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Conjunctivitis  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Lower respiratory tract infection  1  1/23 (4.35%)  1 2/24 (8.33%)  2 1/17 (5.88%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1
Nasopharyngitis  1  1/23 (4.35%)  1 2/24 (8.33%)  2 1/17 (5.88%)  1 1/18 (5.56%)  1 2/18 (11.11%)  2
Rhinitis  1  0/23 (0.00%)  0 2/24 (8.33%)  2 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
Upper respiratory tract infection  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1
Urinary tract infection  1  0/23 (0.00%)  0 2/24 (8.33%)  2 0/17 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1
Injury, poisoning and procedural complications           
Accidental overdose  1  1/23 (4.35%)  1 0/24 (0.00%)  0 2/17 (11.76%)  3 3/18 (16.67%)  4 0/18 (0.00%)  0
Skin abrasion  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  2 0/18 (0.00%)  0
Investigations           
Blood potassium increased  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Haemoglobin decreased  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 2/18 (11.11%)  2 0/18 (0.00%)  0
Metabolism and nutrition disorders           
Decreased appetite  1  0/23 (0.00%)  0 4/24 (16.67%)  4 0/17 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1
Type 2 diabetes mellitus  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Arthralgia  1  1/23 (4.35%)  1 0/24 (0.00%)  0 2/17 (11.76%)  3 3/18 (16.67%)  3 2/18 (11.11%)  2
Back pain  1  1/23 (4.35%)  1 2/24 (8.33%)  2 1/17 (5.88%)  1 1/18 (5.56%)  1 0/18 (0.00%)  0
Bone pain  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Costochondritis  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Haemarthrosis  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Joint effusion  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Musculoskeletal chest pain  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Musculoskeletal discomfort  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Musculoskeletal pain  1  0/23 (0.00%)  0 1/24 (4.17%)  1 1/17 (5.88%)  1 1/18 (5.56%)  1 0/18 (0.00%)  0
Myalgia  1  0/23 (0.00%)  0 1/24 (4.17%)  2 4/17 (23.53%)  5 2/18 (11.11%)  2 1/18 (5.56%)  1
Neck pain  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Pain in extremity  1  2/23 (8.70%)  2 0/24 (0.00%)  0 4/17 (23.53%)  4 0/18 (0.00%)  0 1/18 (5.56%)  1
Nervous system disorders           
Amnesia  1  1/23 (4.35%)  2 0/24 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Disturbance in attention  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Dizziness  1  1/23 (4.35%)  1 3/24 (12.50%)  3 0/17 (0.00%)  0 3/18 (16.67%)  3 1/18 (5.56%)  1
Dysgeusia  1  1/23 (4.35%)  1 1/24 (4.17%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Headache  1  5/23 (21.74%)  6 7/24 (29.17%)  7 5/17 (29.41%)  7 11/18 (61.11%)  12 7/18 (38.89%)  7
Hypersomnia  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Hypoaesthesia  1  1/23 (4.35%)  1 0/24 (0.00%)  0 2/17 (11.76%)  3 0/18 (0.00%)  0 0/18 (0.00%)  0
Lethargy  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Memory impairment  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Nystagmus  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Paraesthesia  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Sinus headache  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Syncope  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Tremor  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Psychiatric disorders           
Anxiety  1  2/23 (8.70%)  2 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1
Depressed mood  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1
Depression  1  0/23 (0.00%)  0 1/24 (4.17%)  1 1/17 (5.88%)  1 1/18 (5.56%)  1 0/18 (0.00%)  0
Emotional disorder  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Euphoric mood  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Hallucination  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Insomnia  1  2/23 (8.70%)  2 0/24 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Irritability  1  2/23 (8.70%)  2 0/24 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Mood swings  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/17 (0.00%)  0 3/18 (16.67%)  3 0/18 (0.00%)  0
Panic attack  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Sleep disorder  1  1/23 (4.35%)  1 0/24 (0.00%)  0 2/17 (11.76%)  2 0/18 (0.00%)  0 0/18 (0.00%)  0
Renal and urinary disorders           
Nephrolithiasis  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Reproductive system and breast disorders           
Nipple pain  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders           
Cough  1  1/23 (4.35%)  1 1/24 (4.17%)  1 1/17 (5.88%)  1 2/18 (11.11%)  2 1/18 (5.56%)  1
Dysphonia  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Dyspnoea  1  1/23 (4.35%)  1 1/24 (4.17%)  1 1/17 (5.88%)  1 3/18 (16.67%)  3 0/18 (0.00%)  0
Dyspnoea exertional  1  3/23 (13.04%)  3 0/24 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
Epistaxis  1  0/23 (0.00%)  0 0/24 (0.00%)  0 2/17 (11.76%)  2 1/18 (5.56%)  1 2/18 (11.11%)  2
Oropharyngeal pain  1  1/23 (4.35%)  1 1/24 (4.17%)  1 1/17 (5.88%)  2 2/18 (11.11%)  2 4/18 (22.22%)  4
Skin and subcutaneous tissue disorders           
Alopecia  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1
Dry skin  1  2/23 (8.70%)  2 1/24 (4.17%)  1 1/17 (5.88%)  1 4/18 (22.22%)  4 1/18 (5.56%)  1
Eczema  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Erythema  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Pruritus  1  0/23 (0.00%)  0 1/24 (4.17%)  1 1/17 (5.88%)  1 5/18 (27.78%)  6 1/18 (5.56%)  1
Rash  1  3/23 (13.04%)  3 1/24 (4.17%)  1 1/17 (5.88%)  2 3/18 (16.67%)  3 1/18 (5.56%)  1
Skin irritation  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Skin lesion  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Vascular disorders           
Hypertension  1  0/23 (0.00%)  0 1/24 (4.17%)  1 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Peripheral coldness  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
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
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02601573     History of Changes
Other Study ID Numbers: 5172-083
2015-003187-37 ( EudraCT Number )
MK-5172-083 ( Other Identifier: Merck Protocol Number )
First Submitted: November 9, 2015
First Posted: November 10, 2015
Results First Submitted: October 12, 2017
Results First Posted: November 13, 2017
Last Update Posted: August 13, 2019