Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079)

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: NCT03379506
Recruitment Status : Completed
First Posted : December 20, 2017
Results First Posted : August 12, 2020
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HCV Infection
Interventions Drug: EBR/GZR
Drug: Placebo
Enrollment 57
Recruitment Details Male and female participants 3 to <18 years of age with chronic hepatitis C virus (HCV) genotype 1 (GT1) or GT4 were enrolled at 14 global study sites.
Pre-assignment Details The present results include data up through the sustained virologic response 12 weeks after completing therapy (SVR12) endpoint cutoff date of 10 April 2020, and will be updated once the final dataset has been analyzed.
Arm/Group Title Age Cohort 1: 12 to <18 Years: Mini and Expanded Age Cohort 2: 7 to <12 Years: Mini and Expanded Age Cohort 3: 3 to <7 Years: Mini Age Cohort 3: 3 to <7 Years: Expanded
Hide Arm/Group Description Pediatric participants 12 to <18 years of age received elbasvir (EBR) 50 mg / grazoprevir (GZR) 100 mg fixed dose combination (FDC) tablets once daily for 12 weeks. Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks. Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg. Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants.
Period Title: Overall Study
Started 22 17 7 11
Completed 22 8 7 0
Not Completed 0 9 0 11
Reason Not Completed
Ongoing in study             0             9             0             11
Arm/Group Title Age Cohort 1: 12 to <18 Years: Mini and Expanded Age Cohort 2: 7 to <12 Years: Mini and Expanded Age Cohort 3: 3 to <7 Years: Mini Age Cohort 3: 3 to <7 Years: Expanded Total
Hide Arm/Group Description Pediatric participants 12 to <18 years of age received EBR/GZR 50 mg/100 mg FDC tablets once daily for 12 weeks. Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks. Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg. Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants. Total of all reporting groups
Overall Number of Baseline Participants 22 17 7 11 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 17 participants 7 participants 11 participants 57 participants
14.1  (1.9) 8.7  (1.2) 3.7  (0.8) 4.8  (1.3) 9.4  (4.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 17 participants 7 participants 11 participants 57 participants
Female
11
  50.0%
7
  41.2%
3
  42.9%
8
  72.7%
29
  50.9%
Male
11
  50.0%
10
  58.8%
4
  57.1%
3
  27.3%
28
  49.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 17 participants 7 participants 11 participants 57 participants
Hispanic or Latino
3
  13.6%
2
  11.8%
1
  14.3%
0
   0.0%
6
  10.5%
Not Hispanic or Latino
19
  86.4%
14
  82.4%
6
  85.7%
11
 100.0%
50
  87.7%
Unknown or Not Reported
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
1
   1.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 17 participants 7 participants 11 participants 57 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
21
  95.5%
17
 100.0%
7
 100.0%
11
 100.0%
56
  98.2%
More than one race
1
   4.5%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Area Under the Plasma Concentration-Time Curve From Dosing to 24 Hours Postdose (AUC0-24hr) of EBR at Steady State
Hide Description The AUC0-24hr of EBR at steady state (Week 4) was determined in each cohort.
Time Frame Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants who complied with the protocol sufficiently to ensure that their pharmacokinetic (PK) data was likely to exhibit the effects of treatment, according to the underlying scientific model, are included.
Arm/Group Title Age Cohort 1: 12 to <18 Years: Mini and Expanded Age Cohort 2: 7 to <12 Years: Mini and Expanded Age Cohort 3: 3 to <7 Years: Mini Age Cohort 3: 3 to <7 Years: Expanded
Hide Arm/Group Description:
Pediatric participants 12 to <18 years of age received EBR/GZR 50 mg/100 mg FDC tablets once daily for 12 weeks.
Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants.
Overall Number of Participants Analyzed 22 17 7 11
Geometric Mean (95% Confidence Interval)
Unit of Measure: µM*hr
2.41
(1.97 to 2.94)
2.79
(2.31 to 3.37)
1.71
(1.36 to 2.15)
3.15
(2.52 to 3.96)
2.Primary Outcome
Title Maximum Plasma Concentration (Cmax) of EBR
Hide Description The Cmax of EBR at steady state (Week 4) was determined in each cohort.
Time Frame Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants who complied with the protocol sufficiently to ensure that their PK data was likely to exhibit the effects of treatment, according to the underlying scientific model, are included.
Arm/Group Title Age Cohort 1: 12 to <18 Years: Mini and Expanded Age Cohort 2: 7 to <12 Years: Mini and Expanded Age Cohort 3: 3 to <7 Years: Mini Age Cohort 3: 3 to <7 Years: Expanded
Hide Arm/Group Description:
Pediatric participants 12 to <18 years of age received EBR/GZR 50 mg/100 mg FDC tablets once daily for 12 weeks.
Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants.
Overall Number of Participants Analyzed 22 17 7 11
Geometric Mean (95% Confidence Interval)
Unit of Measure: µM
0.19
(0.15 to 0.23)
0.21
(0.17 to 0.25)
0.14
(0.11 to 0.19)
0.28
(0.22 to 0.36)
3.Primary Outcome
Title Steady State Predose Drug Concentration (Ctrough) of EBR
Hide Description The Ctrough of EBR at steady state (Week 4) was determined at steady state prior to dosing in each cohort.
Time Frame Week 4: Predose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants who complied with the protocol sufficiently to ensure that their PK data was likely to exhibit the effects of treatment, according to the underlying scientific model, are included. One participant in Age Cohort 2: 7 to <12 Years: Mini and Expanded had missing Ctrough data.
Arm/Group Title Age Cohort 1: 12 to <18 Years: Mini and Expanded Age Cohort 2: 7 to <12 Years: Mini and Expanded Age Cohort 3: 3 to <7 Years: Mini Age Cohort 3: 3 to <7 Years: Expanded
Hide Arm/Group Description:
Pediatric participants 12 to <18 years of age received EBR/GZR 50 mg/100 mg FDC tablets once daily for 12 weeks.
Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants.
Overall Number of Participants Analyzed 22 16 7 11
Geometric Mean (95% Confidence Interval)
Unit of Measure: nM
59.76
(47.20 to 75.67)
59.43
(48.67 to 72.58)
34.61
(28.00 to 42.77)
68.92
(54.32 to 87.44)
4.Primary Outcome
Title Apparent Clearance (CL/F) of EBR at Steady State
Hide Description The CL/F of EBR at steady state (Week 4) was determined in each cohort.
Time Frame Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants who complied with the protocol sufficiently to ensure that their PK data was likely to exhibit the effects of treatment, according to the underlying scientific model, are included.
Arm/Group Title Age Cohort 1: 12 to <18 Years: Mini and Expanded Age Cohort 2: 7 to <12 Years: Mini and Expanded Age Cohort 3: 3 to <7 Years: Mini Age Cohort 3: 3 to <7 Years: Expanded
Hide Arm/Group Description:
Pediatric participants 12 to <18 years of age received EBR/GZR 50 mg/100 mg FDC tablets once daily for 12 weeks.
Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants.
Overall Number of Participants Analyzed 22 17 7 11
Geometric Mean (95% Confidence Interval)
Unit of Measure: L/hr
23.53
(19.25 to 28.75)
12.21
(10.10 to 14.75)
9.94
(7.89 to 12.53)
8.98
(7.16 to 11.27)
5.Primary Outcome
Title AUC0-24hr of GZR at Steady State
Hide Description The AUC0-24hr of GZR at steady state (Week 4) was determined in each cohort.
Time Frame Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants who complied with the protocol sufficiently to ensure that their PK data was likely to exhibit the effects of treatment, according to the underlying scientific model, are included.
Arm/Group Title Age Cohort 1: 12 to <18 Years: Mini and Expanded Age Cohort 2: 7 to <12 Years: Mini and Expanded Age Cohort 3: 3 to <7 Years: Mini Age Cohort 3: 3 to <7 Years: Expanded
Hide Arm/Group Description:
Pediatric participants 12 to <18 years of age received EBR/GZR 50 mg/100 mg FDC tablets once daily for 12 weeks.
Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants.
Overall Number of Participants Analyzed 22 17 7 11
Geometric Mean (95% Confidence Interval)
Unit of Measure: µM*hr
1.45
(1.08 to 1.94)
1.42
(1.00 to 2.02)
0.77
(0.48 to 1.23)
1.66
(1.16 to 2.39)
6.Primary Outcome
Title Cmax of GZR
Hide Description The Cmax of GZR at steady state (Week 4) was determined in each cohort.
Time Frame Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants who complied with the protocol sufficiently to ensure that their PK data was likely to exhibit the effects of treatment, according to the underlying scientific model, are included.
Arm/Group Title Age Cohort 1: 12 to <18 Years: Mini and Expanded Age Cohort 2: 7 to <12 Years: Mini and Expanded Age Cohort 3: 3 to <7 Years: Mini Age Cohort 3: 3 to <7 Years: Expanded
Hide Arm/Group Description:
Pediatric participants 12 to <18 years of age received EBR/GZR 50 mg/100 mg FDC tablets once daily for 12 weeks.
Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants.
Overall Number of Participants Analyzed 22 17 7 11
Geometric Mean (95% Confidence Interval)
Unit of Measure: µM
0.25
(0.17 to 0.35)
0.19
(0.12 to 0.31)
0.09
(0.05 to 0.18)
0.29
(0.18 to 0.47)
7.Primary Outcome
Title Ctrough of GZR
Hide Description The Ctrough of GZR at steady state (Week 4) was determined at steady state prior to dosing in each cohort.
Time Frame Week 4: Predose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants who complied with the protocol sufficiently to ensure that their PK data was likely to exhibit the effects of treatment, according to the underlying scientific model, are included. One participant in Age Cohort 2: 7 to <12 Years: Mini and Expanded had missing Ctrough data.
Arm/Group Title Age Cohort 1: 12 to <18 Years: Mini and Expanded Age Cohort 2: 7 to <12 Years: Mini and Expanded Age Cohort 3: 3 to <7 Years: Mini Age Cohort 3: 3 to <7 Years: Expanded
Hide Arm/Group Description:
Pediatric participants 12 to <18 years of age received EBR/GZR 50 mg/100 mg FDC tablets once daily for 12 weeks.
Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants.
Overall Number of Participants Analyzed 22 16 7 11
Geometric Mean (95% Confidence Interval)
Unit of Measure: nM
16.20
(12.27 to 21.38)
16.27
(11.97 to 22.10)
13.79
(9.55 to 19.90)
16.17
(12.78 to 20.45)
8.Primary Outcome
Title CL/F of GZR at Steady State
Hide Description The CL/F of GZR at steady state (Week 4) was determined in each cohort.
Time Frame Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
No participants are included in the analysis as the CL/F of GZR was not calculable due to nonlinear PK.
Arm/Group Title Age Cohort 1: 12 to <18 Years: Mini and Expanded Age Cohort 2: 7 to <12 Years: Mini and Expanded Age Cohort 3: 3 to <7 Years: Mini Age Cohort 3: 3 to <7 Years: Expanded
Hide Arm/Group Description:
Pediatric participants 12 to <18 years of age received EBR/GZR 50 mg/100 mg FDC tablets once daily for 12 weeks.
Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Percentage of Participants With ≥1 Adverse Event (AE)
Hide Description The percentage of participants with ≥1 AE is reported in each cohort. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time Frame Up to 14 weeks (12 weeks of treatment + first 14 days of follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug are included.
Arm/Group Title Age Cohort 1: 12 to <18 Years: Mini and Expanded Age Cohort 2: 7 to <12 Years: Mini and Expanded Age Cohort 3: 3 to <7 Years: Mini Age Cohort 3: 3 to <7 Years: Expanded
Hide Arm/Group Description:
Pediatric participants 12 to <18 years of age received EBR/GZR 50 mg/100 mg FDC tablets once daily for 12 weeks.
Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants.
Overall Number of Participants Analyzed 22 17 7 11
Measure Type: Number
Unit of Measure: Percentage of Participants
77.3 76.5 85.7 63.6
10.Secondary Outcome
Title Percentage of Participants Discontinuing Study Treatment Due to an AE
Hide Description The percentage of participants discontinuing study therapy due to an AE is reported in each cohort. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug are included.
Arm/Group Title Age Cohort 1: 12 to <18 Years: Mini and Expanded Age Cohort 2: 7 to <12 Years: Mini and Expanded Age Cohort 3: 3 to <7 Years: Mini Age Cohort 3: 3 to <7 Years: Expanded
Hide Arm/Group Description:
Pediatric participants 12 to <18 years of age received EBR/GZR 50 mg/100 mg FDC tablets once daily for 12 weeks.
Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants.
Overall Number of Participants Analyzed 22 17 7 11
Measure Type: Number
Unit of Measure: Percentage of Participants
0.0 0.0 0.0 0.0
11.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Treatment (SVR12)
Hide Description The percentage of participants achieving SVR12, defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after completing study therapy, was determined in each cohort.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study treatment are included.
Arm/Group Title Age Cohort 1: 12 to <18 Years: Mini and Expanded Age Cohort 2: 7 to <12 Years: Mini and Expanded Age Cohort 3: 3 to <7 Years: Mini Age Cohort 3: 3 to <7 Years: Expanded
Hide Arm/Group Description:
Pediatric participants 12 to <18 years of age received EBR/GZR 50 mg/100 mg FDC tablets once daily for 12 weeks.
Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg.
Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants.
Overall Number of Participants Analyzed 22 17 7 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
100.0
(84.6 to 100.0)
100.0
(80.5 to 100.0)
100.0
(59.0 to 100.0)
100.0
(71.5 to 100.0)
Time Frame Up to 36 weeks (up to approximately 21 months for all-cause mortality)
Adverse Event Reporting Description All participants who received ≥1 dose of study drug are included.
 
Arm/Group Title Age Cohort 1: 12 to < 18 Years Age Cohort 2: 7 to < 12 Years Age Cohort 3 Mini: 3 to < 7 Years Age Cohort 3 Expanded: 3 to < 7 Years
Hide Arm/Group Description Pediatric participants 12 to <18 years of age received EBR/GZR 50 mg/100 mg FDC tablets once daily for 12 weeks. Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks. Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg. Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants.
All-Cause Mortality
Age Cohort 1: 12 to < 18 Years Age Cohort 2: 7 to < 12 Years Age Cohort 3 Mini: 3 to < 7 Years Age Cohort 3 Expanded: 3 to < 7 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)      0/17 (0.00%)      0/7 (0.00%)      0/11 (0.00%)    
Hide Serious Adverse Events
Age Cohort 1: 12 to < 18 Years Age Cohort 2: 7 to < 12 Years Age Cohort 3 Mini: 3 to < 7 Years Age Cohort 3 Expanded: 3 to < 7 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/22 (4.55%)      0/17 (0.00%)      0/7 (0.00%)      1/11 (9.09%)    
Gastrointestinal disorders         
Dyspepsia  1  0/22 (0.00%)  0 0/17 (0.00%)  0 0/7 (0.00%)  0 1/11 (9.09%)  1
Injury, poisoning and procedural complications         
Hand fracture  1  1/22 (4.55%)  1 0/17 (0.00%)  0 0/7 (0.00%)  0 0/11 (0.00%)  0
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Age Cohort 1: 12 to < 18 Years Age Cohort 2: 7 to < 12 Years Age Cohort 3 Mini: 3 to < 7 Years Age Cohort 3 Expanded: 3 to < 7 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/22 (72.73%)      13/17 (76.47%)      6/7 (85.71%)      8/11 (72.73%)    
Gastrointestinal disorders         
Abdominal pain  1  1/22 (4.55%)  1 1/17 (5.88%)  1 1/7 (14.29%)  1 0/11 (0.00%)  0
Abdominal pain upper  1  3/22 (13.64%)  5 1/17 (5.88%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0
Constipation  1  1/22 (4.55%)  1 0/17 (0.00%)  0 1/7 (14.29%)  1 2/11 (18.18%)  2
Diarrhoea  1  1/22 (4.55%)  1 1/17 (5.88%)  1 1/7 (14.29%)  1 0/11 (0.00%)  0
Gastritis  1  0/22 (0.00%)  0 0/17 (0.00%)  0 0/7 (0.00%)  0 1/11 (9.09%)  2
Nausea  1  4/22 (18.18%)  5 0/17 (0.00%)  0 0/7 (0.00%)  0 0/11 (0.00%)  0
Vomiting  1  3/22 (13.64%)  3 1/17 (5.88%)  1 0/7 (0.00%)  0 3/11 (27.27%)  5
General disorders         
Energy increased  1  0/22 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0
Fatigue  1  2/22 (9.09%)  2 2/17 (11.76%)  2 1/7 (14.29%)  1 0/11 (0.00%)  0
Pyrexia  1  3/22 (13.64%)  3 0/17 (0.00%)  0 0/7 (0.00%)  0 0/11 (0.00%)  0
Infections and infestations         
Bronchitis  1  0/22 (0.00%)  0 0/17 (0.00%)  0 1/7 (14.29%)  1 2/11 (18.18%)  2
Ear infection  1  0/22 (0.00%)  0 1/17 (5.88%)  1 1/7 (14.29%)  2 0/11 (0.00%)  0
Folliculitis  1  0/22 (0.00%)  0 0/17 (0.00%)  0 0/7 (0.00%)  0 1/11 (9.09%)  1
Gastroenteritis  1  1/22 (4.55%)  1 0/17 (0.00%)  0 0/7 (0.00%)  0 1/11 (9.09%)  1
Gastroenteritis viral  1  1/22 (4.55%)  1 0/17 (0.00%)  0 1/7 (14.29%)  1 1/11 (9.09%)  3
Herpes zoster  1  0/22 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0
Impetigo  1  0/22 (0.00%)  0 0/17 (0.00%)  0 1/7 (14.29%)  1 0/11 (0.00%)  0
Influenza  1  0/22 (0.00%)  0 0/17 (0.00%)  0 0/7 (0.00%)  0 1/11 (9.09%)  1
Nasopharyngitis  1  3/22 (13.64%)  6 1/17 (5.88%)  2 1/7 (14.29%)  1 0/11 (0.00%)  0
Otitis media  1  1/22 (4.55%)  1 0/17 (0.00%)  0 0/7 (0.00%)  0 1/11 (9.09%)  1
Pharyngitis streptococcal  1  0/22 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0
Respiratory tract infection  1  0/22 (0.00%)  0 2/17 (11.76%)  4 1/7 (14.29%)  1 3/11 (27.27%)  3
Rhinitis  1  2/22 (9.09%)  2 0/17 (0.00%)  0 0/7 (0.00%)  0 0/11 (0.00%)  0
Sinusitis  1  0/22 (0.00%)  0 0/17 (0.00%)  0 0/7 (0.00%)  0 1/11 (9.09%)  1
Tonsillitis  1  0/22 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0
Upper respiratory tract infection  1  0/22 (0.00%)  0 3/17 (17.65%)  3 1/7 (14.29%)  1 3/11 (27.27%)  3
Viral upper respiratory tract infection  1  0/22 (0.00%)  0 0/17 (0.00%)  0 0/7 (0.00%)  0 1/11 (9.09%)  1
Injury, poisoning and procedural complications         
Accidental overdose  1  1/22 (4.55%)  1 0/17 (0.00%)  0 1/7 (14.29%)  1 0/11 (0.00%)  0
Animal bite  1  0/22 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0
Contusion  1  0/22 (0.00%)  0 1/17 (5.88%)  2 0/7 (0.00%)  0 0/11 (0.00%)  0
Intentional overdose  1  0/22 (0.00%)  0 0/17 (0.00%)  0 1/7 (14.29%)  1 1/11 (9.09%)  3
Post procedural discomfort  1  0/22 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0
Skin laceration  1  0/22 (0.00%)  0 1/17 (5.88%)  1 1/7 (14.29%)  1 0/11 (0.00%)  0
Upper limb fracture  1  0/22 (0.00%)  0 0/17 (0.00%)  0 1/7 (14.29%)  1 0/11 (0.00%)  0
Investigations         
Alanine aminotransferase increased  1  0/22 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0
Blood calcium decreased  1  0/22 (0.00%)  0 0/17 (0.00%)  0 1/7 (14.29%)  1 0/11 (0.00%)  0
Body temperature increased  1  2/22 (9.09%)  2 0/17 (0.00%)  0 0/7 (0.00%)  0 0/11 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite  1  0/22 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0
Hypocalcaemia  1  0/22 (0.00%)  0 0/17 (0.00%)  0 0/7 (0.00%)  0 1/11 (9.09%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Skin papilloma  1  0/22 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0
Nervous system disorders         
Dizziness  1  3/22 (13.64%)  3 0/17 (0.00%)  0 0/7 (0.00%)  0 0/11 (0.00%)  0
Headache  1  8/22 (36.36%)  14 2/17 (11.76%)  4 0/7 (0.00%)  0 2/11 (18.18%)  3
Psychiatric disorders         
Anxiety  1  0/22 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0
Behaviour disorder  1  0/22 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0
Provisional tic disorder  1  0/22 (0.00%)  0 0/17 (0.00%)  0 0/7 (0.00%)  0 1/11 (9.09%)  1
Restlessness  1  0/22 (0.00%)  0 0/17 (0.00%)  0 1/7 (14.29%)  1 0/11 (0.00%)  0
Renal and urinary disorders         
Proteinuria  1  1/22 (4.55%)  2 1/17 (5.88%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  1/22 (4.55%)  1 1/17 (5.88%)  1 1/7 (14.29%)  1 0/11 (0.00%)  0
Epistaxis  1  1/22 (4.55%)  1 0/17 (0.00%)  0 1/7 (14.29%)  1 0/11 (0.00%)  0
Oropharyngeal pain  1  1/22 (4.55%)  1 1/17 (5.88%)  1 0/7 (0.00%)  0 1/11 (9.09%)  1
Rhinitis allergic  1  0/22 (0.00%)  0 0/17 (0.00%)  0 1/7 (14.29%)  1 0/11 (0.00%)  0
Rhinorrhoea  1  1/22 (4.55%)  1 1/17 (5.88%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0
Sneezing  1  0/22 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0
Skin and subcutaneous tissue disorders         
Alopecia  1  0/22 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0
Rash  1  0/22 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0
Urticaria  1  1/22 (4.55%)  1 1/17 (5.88%)  1 0/7 (0.00%)  0 0/11 (0.00%)  0
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
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 results of this study may be published or presented at scientific meetings. The sponsor will comply with the requirements for publication of study results. In accordance with standard editorial and ethical practice, the sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. If publication activity is not directed by the sponsor, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission.
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: NCT03379506    
Other Study ID Numbers: 5172-079
2015-003006-16 ( EudraCT Number )
MK-5172-079 ( Other Identifier: Merck Protocol Number )
First Submitted: December 13, 2017
First Posted: December 20, 2017
Results First Submitted: July 29, 2020
Results First Posted: August 12, 2020
Last Update Posted: August 17, 2020