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Trial record 35 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052) (C-SURFER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02092350
Recruitment Status : Completed
First Posted : March 20, 2014
Results First Posted : April 12, 2016
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hepatitis C Virus
Interventions Drug: Grazoprevir
Drug: Elbasvir
Drug: Placebo to Grazoprevir
Drug: Placebo to Elbasvir
Enrollment 237
Recruitment Details This multi-site study enrolled adult, male and female participants with hepatitis C virus (HCV) genotype (GT) 1 with chronic kidney disease (CKD).
Pre-assignment Details The screening period lasted for up to 60 days.
Arm/Group Title Immediate Treatment + Intensive PK Deferred Treatment
Hide Arm/Group Description Participants received grazoprevir (GZR) 100 mg tablet + elbasvir (EBR) 50 mg tablet once daily (q.d.) by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive pharmacokinetics (PK) testing. Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a fixed dose combination (FDC) tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
Period Title: Overall Study
Started 123 114
Completed 113 102
Not Completed 10 12
Reason Not Completed
Adverse Event             0             3
Death             2             5
Lost to Follow-up             3             1
Protocol Violation             1             0
Physician Decision             1             1
Screen Failure             1             0
Withdrawal by Subject             2             2
Arm/Group Title Immediate Treatment + Intensive PK Deferred Treatment Total
Hide Arm/Group Description Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing. Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. Total of all reporting groups
Overall Number of Baseline Participants 123 114 237
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 123 participants 114 participants 237 participants
56.6  (9.0) 55.2  (10.0) 55.9  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 114 participants 237 participants
Female
30
  24.4%
33
  28.9%
63
  26.6%
Male
93
  75.6%
81
  71.1%
174
  73.4%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)
Hide Description SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) lower than the limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.
Time Frame Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The modified Full Analysis set (mFAS) includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.
Arm/Group Title Immediate Treatment + Intensive PK Deferred Treatment
Hide Arm/Group Description:
Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
Overall Number of Participants Analyzed 116 99
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
99.1
(95.3 to 100.0)
98.0
(92.9 to 99.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate Treatment + Intensive PK
Comments The primary hypothesis was that the SVR12 rate in the Immediate Treatment plus Intensive PK arm would be >45%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method One-sided exact test
Comments [Not Specified]
2.Primary Outcome
Title Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods
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. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.
Time Frame Up to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The All Participants as Treated (APaT) population includes all enrolled participants who received at least one dose of study drug.
Arm/Group Title Immediate Treatment + Intensive PK Deferred Treatment
Hide Arm/Group Description:
Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
Overall Number of Participants Analyzed 122 113
Measure Type: Number
Unit of Measure: Participants
93 96
3.Primary Outcome
Title Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period
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. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The APaT population includes all enrolled participants who received at least one dose of study drug.
Arm/Group Title Immediate Treatment + Intensive PK Deferred Treatment
Hide Arm/Group Description:
Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
Overall Number of Participants Analyzed 122 113
Measure Type: Number
Unit of Measure: Participants
0 5
4.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)
Hide Description SVR24 was defined as HCV RNA <LLoQ 24 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.
Time Frame Week 36 (Immediate Treatment + Intensive PK) or Week 52 (Deferred Treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The mFAS includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.
Arm/Group Title Immediate Treatment + Intensive PK Deferred Treatment Group
Hide Arm/Group Description:
Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
Overall Number of Participants Analyzed 114 99
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
97.4
(92.5 to 99.5)
98.0
(92.9 to 99.8)
5.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 4 Weeks After Completing Study Therapy (SVR4)
Hide Description SVR4 was defined as HCV RNA <LLoQ 4 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.
Time Frame Week 16 (Immediate Treatment + Intensive PK) or Week 32 (Deferred Treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The mFAS includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.
Arm/Group Title Immediate Treatment + Intensive PK Deferred Treatment Group
Hide Arm/Group Description:
Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
Overall Number of Participants Analyzed 118 101
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
100.00
(96.9 to 100.0)
99.0
(94.6 to 100.0)
Time Frame Immediate Treatment + Intensive PK: up to Week 36; Deferred Treatment GZR Placebo + EBR Placebo: up to Week 16; Deferred Treatment GZR 100 mg + EBR 50 mg: Week 16 to up to Week 52.
Adverse Event Reporting Description AE data is presented for APaT (all participants receiving ≥1 dose of study drug).
 
Arm/Group Title Immediate Treatment + Intensive PK Deferred Treatment: GZR Placebo + EBR Placebo 12 Weeks Deferred Treatment: GZR 100 mg + EBR 50 mg 12 Weeks
Hide Arm/Group Description Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing. Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks, followed by a 4-week drug-free period. Participants received a FDC tablet containing GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
All-Cause Mortality
Immediate Treatment + Intensive PK Deferred Treatment: GZR Placebo + EBR Placebo 12 Weeks Deferred Treatment: GZR 100 mg + EBR 50 mg 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Immediate Treatment + Intensive PK Deferred Treatment: GZR Placebo + EBR Placebo 12 Weeks Deferred Treatment: GZR 100 mg + EBR 50 mg 12 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/122 (24.59%)      22/113 (19.47%)      25/102 (24.51%)    
Blood and lymphatic system disorders       
Anaemia  2  0/122 (0.00%)  0 0/113 (0.00%)  0 3/102 (2.94%)  3
Iron deficiency anaemia  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Cardiac disorders       
Acute myocardial infarction  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Angina unstable  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Atrial fibrillation  1  0/122 (0.00%)  0 1/113 (0.88%)  1 2/102 (1.96%)  3
Cardiac arrest  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Cardiac failure congestive  1  2/122 (1.64%)  2 0/113 (0.00%)  0 0/102 (0.00%)  0
Cardiomyopathy  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Myocardial infarction  1  1/122 (0.82%)  1 1/113 (0.88%)  1 0/102 (0.00%)  0
Coronary artery occlusion  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Pericardial effusion  2  0/122 (0.00%)  0 1/113 (0.88%)  1 1/102 (0.98%)  1
Pericarditis  2  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Tricuspid valve incompetence  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Cardiac failure  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Gastrointestinal disorders       
Abdominal pain  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Abdominal pain upper  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Constipation  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Diarrhoea  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Gastritis  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Localised intraabdominal fluid collection  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Pancreatitis  1  1/122 (0.82%)  1 1/113 (0.88%)  1 0/102 (0.00%)  0
Upper gastrointestinal haemorrhage  1  0/122 (0.00%)  0 2/113 (1.77%)  2 0/102 (0.00%)  0
Vomiting  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Gastrointestinal haemorrhage  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Retroperitoneal haematoma  2  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
General disorders       
Chest pain  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Death  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Non-cardiac chest pain  1  1/122 (0.82%)  1 0/113 (0.00%)  0 1/102 (0.98%)  1
Pyrexia  1  2/122 (1.64%)  2 0/113 (0.00%)  0 1/102 (0.98%)  1
Infections and infestations       
Abscess limb  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Appendicitis  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Citrobacter sepsis  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Enterobacter sepsis  1  1/122 (0.82%)  2 0/113 (0.00%)  0 0/102 (0.00%)  0
Haematoma infection  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Infected fistula  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Lower respiratory tract infection  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Osteomyelitis  1  1/122 (0.82%)  1 1/113 (0.88%)  1 0/102 (0.00%)  0
Pneumonia  1  2/122 (1.64%)  2 1/113 (0.88%)  1 3/102 (2.94%)  3
Postoperative wound infection  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Sepsis  1  2/122 (1.64%)  2 0/113 (0.00%)  0 0/102 (0.00%)  0
Gastroenteritis  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Mediastinitis  2  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Nocardiosis  2  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Pneumonia bacterial  2  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Septic shock  2  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Urinary tract infection  2  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Injury, poisoning and procedural complications       
Arteriovenous fistula aneurysm  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Arteriovenous fistula site complication  1  1/122 (0.82%)  1 1/113 (0.88%)  1 0/102 (0.00%)  0
Dialysis related complication  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Foreign body  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Genital injury  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Postoperative fever  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Procedural pain  1  2/122 (1.64%)  2 0/113 (0.00%)  0 0/102 (0.00%)  0
Wound dehiscence  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Facial bones fracture  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Post procedural haematoma  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Subdural haematoma  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Investigations       
Blood alkaline phosphatase increased  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Electrocardiogram abnormal  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Lipase increased  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  1/122 (0.82%)  1 0/113 (0.00%)  0 1/102 (0.98%)  1
Fluid overload  1  1/122 (0.82%)  1 1/113 (0.88%)  2 0/102 (0.00%)  0
Hyperglycaemia  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Hyperkalaemia  1  1/122 (0.82%)  1 1/113 (0.88%)  1 0/102 (0.00%)  0
Hyponatraemia  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  2
Musculoskeletal and connective tissue disorders       
Costochondritis  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Intervertebral disc protrusion  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Myositis  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Pain in extremity  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Papillary thyroid cancer  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Prostate cancer  1  1/122 (0.82%)  1 1/113 (0.88%)  1 0/102 (0.00%)  0
Nervous system disorders       
Depressed level of consciousness  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Dizziness  1  0/122 (0.00%)  0 1/113 (0.88%)  1 1/102 (0.98%)  2
Headache  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Hemiparesis  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Presyncope  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Encephalopathy  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Hepatic encephalopathy  2  0/122 (0.00%)  0 1/113 (0.88%)  1 1/102 (0.98%)  1
Hydrocephalus  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Intraventricular haemorrhage  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Nervous system disorder  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Seizure  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Psychiatric disorders       
Disorientation  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Renal and urinary disorders       
Acute kidney injury  2  0/122 (0.00%)  0 0/113 (0.00%)  0 3/102 (2.94%)  3
Chronic kidney disease  2  1/122 (0.82%)  1 1/113 (0.88%)  1 1/102 (0.98%)  1
Tubulointerstitial nephritis  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Pleural effusion  1  1/122 (0.82%)  1 1/113 (0.88%)  1 0/102 (0.00%)  0
Acute pulmonary oedema  2  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Chronic obstructive pulmonary disease  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Hypoxia  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Mediastinal effusion  2  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Pneumothorax  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Pulmonary oedema  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Aortic stenosis  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Vascular disorders       
Aortic aneurysm  1  0/122 (0.00%)  0 2/113 (1.77%)  2 0/102 (0.00%)  0
Cryoglobulinaemia  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Extremity necrosis  1  1/122 (0.82%)  2 0/113 (0.00%)  0 0/102 (0.00%)  0
Hypertension  1  2/122 (1.64%)  3 1/113 (0.88%)  1 0/102 (0.00%)  0
Hypertensive crisis  1  1/122 (0.82%)  1 0/113 (0.00%)  0 0/102 (0.00%)  0
Orthostatic hypotension  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Peripheral venous disease  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Shock haemorrhagic  1  0/122 (0.00%)  0 1/113 (0.88%)  1 0/102 (0.00%)  0
Aortic stenosis  2  0/122 (0.00%)  0 0/113 (0.00%)  0 1/102 (0.98%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
2
Term from vocabulary, MedDRA v. 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Immediate Treatment + Intensive PK Deferred Treatment: GZR Placebo + EBR Placebo 12 Weeks Deferred Treatment: GZR 100 mg + EBR 50 mg 12 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   67/122 (54.92%)      68/113 (60.18%)      39/102 (38.24%)    
Gastrointestinal disorders       
Abdominal discomfort  1  2/122 (1.64%)  2 6/113 (5.31%)  6 1/102 (0.98%)  1
Abdominal pain  1  10/122 (8.20%)  13 3/113 (2.65%)  3 3/102 (2.94%)  3
Constipation  1  8/122 (6.56%)  8 6/113 (5.31%)  7 3/102 (2.94%)  3
Diarrhoea  1  6/122 (4.92%)  6 15/113 (13.27%)  22 5/102 (4.90%)  6
Nausea  1  18/122 (14.75%)  24 18/113 (15.93%)  21 11/102 (10.78%)  12
Vomiting  1  9/122 (7.38%)  13 9/113 (7.96%)  11 7/102 (6.86%)  10
General disorders       
Asthenia  1  7/122 (5.74%)  9 6/113 (5.31%)  6 4/102 (3.92%)  4
Fatigue  1  13/122 (10.66%)  15 17/113 (15.04%)  17 10/102 (9.80%)  10
Pyrexia  1  6/122 (4.92%)  7 6/113 (5.31%)  6 3/102 (2.94%)  4
Metabolism and nutrition disorders       
Decreased appetite  1  7/122 (5.74%)  8 3/113 (2.65%)  3 4/102 (3.92%)  4
Musculoskeletal and connective tissue disorders       
Musculoskeletal pain  1  0/122 (0.00%)  0 6/113 (5.31%)  6 1/102 (0.98%)  1
Myalgia  1  0/122 (0.00%)  0 8/113 (7.08%)  9 2/102 (1.96%)  2
Nervous system disorders       
Dizziness  1  8/122 (6.56%)  9 18/113 (15.93%)  22 4/102 (3.92%)  4
Headache  1  23/122 (18.85%)  26 18/113 (15.93%)  23 7/102 (6.86%)  8
Psychiatric disorders       
Insomnia  1  10/122 (8.20%)  10 12/113 (10.62%)  12 2/102 (1.96%)  2
Respiratory, thoracic and mediastinal disorders       
Cough  1  9/122 (7.38%)  10 2/113 (1.77%)  2 5/102 (4.90%)  6
Skin and subcutaneous tissue disorders       
Pruritus  1  4/122 (3.28%)  4 12/113 (10.62%)  12 1/102 (0.98%)  1
Vascular disorders       
Hypertension  1  7/122 (5.74%)  7 6/113 (5.31%)  6 2/102 (1.96%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 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
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: ClinicalTrialDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02092350     History of Changes
Other Study ID Numbers: 5172-052
2013-003858-25 ( EudraCT Number )
First Submitted: March 17, 2014
First Posted: March 20, 2014
Results First Submitted: February 3, 2016
Results First Posted: April 12, 2016
Last Update Posted: September 24, 2018