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The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)

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ClinicalTrials.gov Identifier: NCT01937975
Recruitment Status : Completed
First Posted : September 10, 2013
Results First Posted : March 4, 2016
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Hepatitis C
Renal Impairment
Interventions Drug: Grazoprevir
Drug: Elbasvir
Enrollment 24
Recruitment Details After enrollment of participants with End Stage Renal Disease and Severe Renal Impairment, healthy participants with matching mean age, body mass index, and gender were enrolled.
Pre-assignment Details  
Arm/Group Title Participants With End Stage Renal Disease on Hemodialysis Participants With Severe Renal Impairment Healthy Participants
Hide Arm/Group Description Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Period Title: Overall Study
Started 8 8 8
Completed 8 8 8
Not Completed 0 0 0
Arm/Group Title Participants With End Stage Renal Disease on Hemodialysis Participants With Severe Renal Impairment Healthy Participants Total
Hide Arm/Group Description Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Total of all reporting groups
Overall Number of Baseline Participants 8 8 8 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 8 participants 24 participants
47.8
(38 to 61)
65.8
(54 to 75)
55.1
(47 to 63)
56.2
(38 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 24 participants
Female
3
  37.5%
4
  50.0%
4
  50.0%
11
  45.8%
Male
5
  62.5%
4
  50.0%
4
  50.0%
13
  54.2%
Estimated Glomerular Filtration Rate   [1] 
Mean (Full Range)
Unit of measure:  mL/min/1.73 m^2
Number Analyzed 8 participants 8 participants 8 participants 24 participants
NA [2] 
(NA to NA)
18.0
(11.5 to 23.5)
93.4
(80.0 to 124.0)
NA [3] 
(NA to NA)
[1]
Measure Description: Glomerular Filtration Rate at baseline was based on the Modification of Diet Renal Disease equation. N=6 instead of 8 for Healthy Participants.
[2]
Not determined for ESRD participants on HD
[3]
Not determined for the overall population
1.Primary Outcome
Title Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Grazoprevir
Hide Description Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)
Time Frame Up to 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Participants With End Stage Renal Disease Participants With Severe Renal Impairment: Day 10 Healthy Participants: Day 10
Hide Arm/Group Description:
Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
Participants with Severe Renal Impairment (SRI, estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Overall Number of Participants Analyzed 8 8 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: uM*hr
Day 9
0.969
(0.689 to 1.36)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Day 10
0.944
(0.671 to 1.33)
1.88
(1.23 to 2.86)
1.14
(0.843 to 1.54)
[1]
No pharmacokinetic sampling on Day 9 for this group
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease
Comments ESRD Non-HD Day 9 versus ESRD HD Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.97
Confidence Interval (2-Sided) 90%
0.87 to 1.09
Estimation Comments Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease, Healthy Participants: Day 10
Comments ESRD Non-HD Day 9 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.85
Confidence Interval (2-Sided) 90%
0.58 to 1.25
Estimation Comments Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease, Healthy Participants: Day 10
Comments ESRD HD Day 10 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.83
Confidence Interval (2-Sided) 90%
0.56 to 1.22
Estimation Comments Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Participants With Severe Renal Impairment: Day 10, Healthy Participants: Day 10
Comments SRI Participants Day 10 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.65
Confidence Interval (2-Sided) 90%
1.09 to 2.49
Estimation Comments Geometric Mean Ratio = SRI Day 10 / Healthy Day 10
2.Primary Outcome
Title Plasma Concentration at 24 Hours Postdose (C24hr) of Grazoprevir
Hide Description Blood for determination of Grazoprevir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)
Time Frame 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Participants With End Stage Renal Disease Participants With Severe Renal Impairment: Day 10 Healthy Participants: Day 10
Hide Arm/Group Description:
Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Overall Number of Participants Analyzed 8 8 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: nM
Day 9
11.4
(8.16 to 16.1)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Day 10
11.3
(8.03 to 15.8)
23.3
(15.4 to 35.2)
14.5
(10.7 to 19.6)
[1]
No pharmacokinetic sampling on Day 9 for this group
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease
Comments ESRD Non-HD Day 9 versus ESRD HD Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.98
Confidence Interval (2-Sided) 90%
0.81 to 1.19
Estimation Comments Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease, Healthy Participants: Day 10
Comments ESRD Non-HD Day 9 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.79
Confidence Interval (2-Sided) 90%
0.54 to 1.16
Estimation Comments Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease, Healthy Participants: Day 10
Comments ESRD HD Day 10 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.78
Confidence Interval (2-Sided) 90%
0.53 to 1.14
Estimation Comments Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Participants With Severe Renal Impairment: Day 10, Healthy Participants: Day 10
Comments SRI Participants Day 10 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.60
Confidence Interval (2-Sided) 90%
1.06 to 2.42
Estimation Comments Geometric Mean Ratio = SRI Day 10 / Healthy Day 10
3.Primary Outcome
Title Maximum Plasma Concentration (Cmax) of Grazoprevir
Hide Description Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9
Time Frame Up to 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Participants With End Stage Renal Disease Participants With Severe Renal Impairment: Day 10 Healthy Participants: Day 10
Hide Arm/Group Description:
Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Overall Number of Participants Analyzed 8 8 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: uM
Day 9
0.141
(0.092 to 0.215)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Day 10
0.135
(0.088 to 0.206)
0.255
(0.152 to 0.429)
0.154
(0.106 to 0.224)
[1]
No pharmacokinetic sampling on Day 9 for this group
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease
Comments ESRD Non-HD Day 9 versus ESRD HD Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 90%
0.75 to 1.22
Estimation Comments Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease, Healthy Participants: Day 10
Comments ESRD Non-HD Day 9 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.92
Confidence Interval (2-Sided) 90%
0.57 to 1.48
Estimation Comments Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease, Healthy Participants: Day 10
Comments ESRD HD Day 10 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.88
Confidence Interval (2-Sided) 90%
0.54 to 1.42
Estimation Comments Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Participants With Severe Renal Impairment: Day 10, Healthy Participants: Day 10
Comments SRI Participants Day 10 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.66
Confidence Interval (2-Sided) 90%
0.99 to 2.77
Estimation Comments Geometric Mean Ratio = SRI Day 10 / Healthy Day 10
4.Primary Outcome
Title Time of Maximum Plasma Concentration (Tmax) of Grazoprevir
Hide Description Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9
Time Frame Up to 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Participants With End Stage Renal Disease Participants With Severe Renal Impairment: Day 10 Healthy Participants: Day 10
Hide Arm/Group Description:
Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Overall Number of Participants Analyzed 8 8 8
Median (Full Range)
Unit of Measure: Hours
Day 9
2.00
(1.00 to 6.00)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Day 10
2.50
(0.50 to 7.00)
3.00
(0.50 to 6.00)
2.50
(1.00 to 6.00)
[1]
No pharmacokinetic sampling on Day 9 for this group
5.Primary Outcome
Title Apparent Terminal Half-life (T1/2) of Grazoprevir
Hide Description Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10
Time Frame Up to 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.
Arm/Group Title Participants With End Stage Renal Disease: HD Day 10 Participants With Severe Renal Impairment: Day 10 Healthy Participants: Day 10
Hide Arm/Group Description:
Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days
Overall Number of Participants Analyzed 8 8 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
28.38
(0.50% to 6.00%)
36.30
(1.00% to 6.00%)
35.18
(19.64%)
6.Primary Outcome
Title Apparent Clearance After Extravascular Administration (CL/F) of Grazoprevir
Hide Description Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)
Time Frame Up to 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Participants With End Stage Renal Disease Participants With Severe Renal Impairment: Day 10 Healthy Participants: Day 10
Hide Arm/Group Description:
Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Overall Number of Participants Analyzed 8 8 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: Liters/hr
Day 9
135
(95.6 to 189)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Day 10
138
(98.1 to 194)
69.4
(45.6 to 106)
114
(84.5 to 155)
[1]
No pharmacokinetic sampling on Day 9 for this group
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease
Comments ESRD Non-HD Day 9 versus ESRD HD Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.03
Confidence Interval (2-Sided) 90%
0.92 to 1.15
Estimation Comments Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease, Healthy Participants: Day 10
Comments ESRD Non-HD Day 9 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.18
Confidence Interval (2-Sided) 90%
0.80 to 1.73
Estimation Comments Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease, Healthy Participants: Day 10
Comments ESRD HD Day 10 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.21
Confidence Interval (2-Sided) 90%
0.82 to 1.78
Estimation Comments Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Participants With Severe Renal Impairment: Day 10, Healthy Participants: Day 10
Comments SRI Participants Day 10 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.61
Confidence Interval (2-Sided) 90%
0.40 to 0.92
Estimation Comments Geometric Mean Ratio = SRI Day 10 / Healthy Day 10
7.Primary Outcome
Title Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Grazoprevir
Hide Description Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10
Time Frame Up to 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.
Arm/Group Title Participants With End Stage Renal Disease: HD Day 10 Participants With Severe Renal Impairment: Day 10 Healthy Participants: Day 10
Hide Arm/Group Description:
Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days
Overall Number of Participants Analyzed 8 8 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: Liters
5430
(3660 to 8050)
3490
(2320 to 5260)
5760
(4180 to 7930)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease: HD Day 10, Healthy Participants: Day 10
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.94
Confidence Interval (2-Sided) 90%
0.63 to 1.42
Estimation Comments Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants With Severe Renal Impairment: Day 10, Healthy Participants: Day 10
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.61
Confidence Interval (2-Sided) 90%
0.39 to 0.94
Estimation Comments Geometric Mean Ratio = SRI Day 10 / Healthy Day 10
8.Primary Outcome
Title Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Elbasvir
Hide Description Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)
Time Frame Up to 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Participants With End Stage Renal Disease Participants With Severe Renal Impairment: Day 10 Healthy Participants: Day 10
Hide Arm/Group Description:
Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
Participants with Severe Renal Impairment (SRI, estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Overall Number of Participants Analyzed 8 8 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: uM*hr
Day 9
1.89
(1.48 to 2.42)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Day 10
2.16
(1.69 to 2.77)
4.07
(3.01 to 5.52)
2.19
(1.76 to 2.72)
[1]
No pharmacokinetic sampling on Day 9 for this group
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease
Comments ESRD Non-HD Day 9 versus ESRD HD Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.14
Confidence Interval (2-Sided) 90%
1.08 to 1.21
Estimation Comments Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease, Healthy Participants: Day 10
Comments ESRD Non-HD Day 9 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.86
Confidence Interval (2-Sided) 90%
0.65 to 1.14
Estimation Comments Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease, Healthy Participants: Day 10
Comments ESRD HD Day 10 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.99
Confidence Interval (2-Sided) 90%
0.75 to 1.30
Estimation Comments Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Participants With Severe Renal Impairment: Day 10, Healthy Participants: Day 10
Comments SRI Participants Day 10 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.86
Confidence Interval (2-Sided) 90%
1.38 to 2.51
Estimation Comments Geometric Mean Ratio = SRI Day 10 / Healthy Day 10
9.Primary Outcome
Title Plasma Concentration at 24 Hours Postdose (C24hr) of Elbasvir
Hide Description Blood for determination of Elbasvir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)
Time Frame 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Participants With End Stage Renal Disease Participants With Severe Renal Impairment: Day 10 Healthy Participants: Day 10
Hide Arm/Group Description:
Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Overall Number of Participants Analyzed 8 8 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: nM
Day 9
46.9
(35.2 to 62.4)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Day 10
58.2
(43.7 to 77.5)
126
(88.6 to 179)
60.9
(47.3 to 78.5)
[1]
No pharmacokinetic sampling on Day 9 for this group
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease
Comments ESRD Non-HD Day 9 versus ESRD HD Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.24
Confidence Interval (2-Sided) 90%
1.17 to 1.32
Estimation Comments Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease, Healthy Participants: Day 10
Comments ESRD Non-HD Day 9 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.77
Confidence Interval (2-Sided) 90%
0.56 to 1.06
Estimation Comments Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease, Healthy Participants: Day 10
Comments ESRD HD Day 10 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.95
Confidence Interval (2-Sided) 90%
0.69 to 1.32
Estimation Comments Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Participants With Severe Renal Impairment: Day 10, Healthy Participants: Day 10
Comments SRI Participants Day 10 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 2.07
Confidence Interval (2-Sided) 90%
1.46 to 2.93
Estimation Comments Geometric Mean Ratio = SRI Day 10 / Healthy Day 10
10.Primary Outcome
Title Maximum Plasma Concentration (Cmax) of Elbasvir
Hide Description Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9
Time Frame Up to 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Participants With End Stage Renal Disease Participants With Severe Renal Impairment: Day 10 Healthy Participants: Day 10
Hide Arm/Group Description:
Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Overall Number of Participants Analyzed 8 8 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: uM
Day 9
0.137
(0.105 to 0.178)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Day 10
0.154
(0.118 to 0.200)
0.271
(0.196 to 0.373)
0.163
(0.129 to 0.206)
[1]
No pharmacokinetic sampling on Day 9 for this group
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease
Comments ESRD Non-HD Day 9 versus ESRD HD Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.12
Confidence Interval (2-Sided) 90%
1.00 to 1.26
Estimation Comments Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease, Healthy Participants: Day 10
Comments ESRD Non-HD Day 9 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.84
Confidence Interval (2-Sided) 90%
0.62 to 1.13
Estimation Comments Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease, Healthy Participants: Day 10
Comments ESRD HD Day 10 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.94
Confidence Interval (2-Sided) 90%
0.70 to 1.27
Estimation Comments Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Participants With Severe Renal Impairment: Day 10, Healthy Participants: Day 10
Comments SRI Participants Day 10 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.66
Confidence Interval (2-Sided) 90%
1.21 to 2.28
Estimation Comments Geometric Mean Ratio = SRI Day 10 / Healthy Day 10
11.Primary Outcome
Title Time of Maximum Plasma Concentration (Tmax) of Elbasvir
Hide Description Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9
Time Frame Up to 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Participants With End Stage Renal Disease Participants With Severe Renal Impairment: Day 10 Healthy Participants: Day 10
Hide Arm/Group Description:
Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Overall Number of Participants Analyzed 8 8 8
Median (Full Range)
Unit of Measure: Hours
Day 9
4.00
(3.00 to 4.00)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Day 10
5.00
(3.00 to 5.00)
4.00
(4.00 to 6.00)
4.00
(2.00 to 4.00)
[1]
No pharmacokinetic sampling on Day 9 for this group
12.Primary Outcome
Title Apparent Terminal Half-life (T1/2) of Elbasvir
Hide Description Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10
Time Frame Up to 120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.
Arm/Group Title Participants With End Stage Renal Disease: HD Day 10 Participants With Severe Renal Impairment: Day 10 Healthy Participants: Day 10
Hide Arm/Group Description:
Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. One participant was excluded due to an ill-defined terminal phase.
Overall Number of Participants Analyzed 8 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
23.04
(0.50% to 6.00%)
28.97
(1.00% to 6.00%)
25.02
(19.08%)
13.Primary Outcome
Title Apparent Clearance After Extravascular Administration (CL/F) of Elbasvir
Hide Description Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)
Time Frame Up to 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Participants With End Stage Renal Disease Participants With Severe Renal Impairment: Day 10 Healthy Participants: Day 10
Hide Arm/Group Description:
Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Overall Number of Participants Analyzed 8 8 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: Liters/hr
Day 9
29.9
(23.4 to 38.3)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Day 10
26.2
(20.5 to 33.5)
13.9
(10.3 to 18.9)
25.9
(20.8 to 32.2)
[1]
No pharmacokinetic sampling on Day 9 for this group
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease
Comments ESRD Non-HD Day 9 versus ESRD HD Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.88
Confidence Interval (2-Sided) 90%
0.83 to 0.92
Estimation Comments Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease, Healthy Participants: Day 10
Comments ESRD Non-HD Day 9 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.16
Confidence Interval (2-Sided) 90%
0.88 to 1.53
Estimation Comments Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease, Healthy Participants: Day 10
Comments ESRD HD Day 10 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 90%
0.77 to 1.34
Estimation Comments Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Participants With Severe Renal Impairment: Day 10, Healthy Participants: Day 10
Comments SRI Participants Day 10 versus Healthy Participants Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.54
Confidence Interval (2-Sided) 90%
0.40 to 0.72
Estimation Comments Geometric Mean Ratio = SRI Day 10 / Healthy Day 10
14.Primary Outcome
Title Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Elbasvir
Hide Description Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10
Time Frame Up to 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.
Arm/Group Title Participants With End Stage Renal Disease: HD Day 10 Participants With Severe Renal Impairment: Day 10 Healthy Participants: Day 10
Hide Arm/Group Description:
Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. One participant was excluded due to an ill-defined terminal phase.
Overall Number of Participants Analyzed 8 8 7
Geometric Mean (95% Confidence Interval)
Unit of Measure: Liters
857
(641 to 1150)
569
(420 to 772)
901
(699 to 1160)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With End Stage Renal Disease: HD Day 10, Healthy Participants: Day 10
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.95
Confidence Interval (2-Sided) 90%
0.70 to 1.30
Estimation Comments Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants With Severe Renal Impairment: Day 10, Healthy Participants: Day 10
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.63
Confidence Interval (2-Sided) 90%
0.45 to 0.89
Estimation Comments Geometric Mean Ratio = SRI Day 10 / Healthy Day 10
Time Frame Up to 14 days after the last dose of study drug (up to 24 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Participants With End Stage Renal Disease on Hemodialysis Participants With Severe Renal Impairment Healthy Participants
Hide Arm/Group Description Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
All-Cause Mortality
Participants With End Stage Renal Disease on Hemodialysis Participants With Severe Renal Impairment Healthy Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Participants With End Stage Renal Disease on Hemodialysis Participants With Severe Renal Impairment Healthy Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/8 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants With End Stage Renal Disease on Hemodialysis Participants With Severe Renal Impairment Healthy Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/8 (50.00%)      3/8 (37.50%)      3/8 (37.50%)    
Gastrointestinal disorders       
Dry mouth  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
Nausea  1  1/8 (12.50%)  1 1/8 (12.50%)  1 0/8 (0.00%)  0
Paraesthesia oral  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Vomiting  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Infections and infestations       
Upper respiratory tract infection  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
Musculoskeletal and connective tissue disorders       
Muscular weakness  1  1/8 (12.50%)  1 1/8 (12.50%)  1 0/8 (0.00%)  0
Myalgia  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Nervous system disorders       
Headache  1  3/8 (37.50%)  3 2/8 (25.00%)  2 2/8 (25.00%)  2
Respiratory, thoracic and mediastinal disorders       
Nasal congestion  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 16.1
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 will provide separate guidance on the criteria for publication of clinical trial data when contacted for permission to publish.
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: NCT01937975     History of Changes
Other Study ID Numbers: 5172-050
First Submitted: September 4, 2013
First Posted: September 10, 2013
Results First Submitted: February 3, 2016
Results First Posted: March 4, 2016
Last Update Posted: June 12, 2019