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CompletedNCT03379506Updated May 31, 2023Results posted

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

A Phase 2 interventional study of EBR/GZR FDC Tablet and Placebo in HCV Infection, sponsored by Merck Sharp & Dohme LLC. Completed at 15 sites in 4 countries. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-05-31.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
57
Allocation
Not applicable
Ages
3 Years to 17 Years
Sex
All
01

Study summary

The purpose of this study is to assess the pharmacokinetics (PK), safety, and efficacy of oral MK-5172 (a fixed dose combination [FDC] tablet containing elbasvir [EBR] 50 mg and grazoprevir [GZR] 100 mg) and EBR/GZR (varying doses) pediatric granules in pediatric hepatitis C virus (HCV)-infected participants who are 3 to \<18 years of age. Within each age cohort (Cohort 1: 12 to \<18 years of age; Cohort 2: 7 to \<12 years of age; and Cohort 3: 3 to \<7 years of age), a Mini Cohort of 7 participants will be enrolled first. For the oldest cohort (Cohort 1), the Mini Cohort will assess ability to swallow a placebo tablet prior to administering active FDC tablets; participants in Cohorts 2 and 3 will take pediatric granules instead of a tablet.

02

Conditions studied

  • HCV Infection
03

Who can participate

Ages eligible
3 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Has documented chronic HCV genotype (GT) 1 or GT4 infection
  • Has the following liver disease staging assessment: absence of cirrhosis or compensated cirrhosis
  • Has one of the following HCV treatment statuses:
  • GT1 and GT4: treatment-naïve (TN), defined as no prior exposure to any interferon (IFN)-containing regimen, ribavirin (RBV), or other HCV-specific direct acting antiviral (DAA) agent
  • GT1 only: treatment-experienced (TE) with no previous treatment with HCV specific DAA agents.
  • If female is not pregnant, not breastfeeding, and is either not of childbearing potential or follows the contraceptive guidance during the treatment period and for at least 14 days after the last dose of study treatment.

Exclusion criteria

Exclusion Criteria:

  • Has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy, or other signs or symptoms of advanced liver disease.
  • Is cirrhotic AND has a Child-Turcotte-Pugh score >6, corresponding to a Child Class B or C.
  • Is co-infected with Human Immunodeficiency Virus (HIV).
  • Has evidence of past or present hepatitis B infection.
  • Has a history of malignancy ≤5 years prior to signing informed consent or is under evaluation for other active or suspected malignancy.
  • Female expects to conceive or donate eggs from Day 1 through at least 14 days after the last dose of study treatment or longer.
  • Has any of the following conditions: organ transplants other than cornea and hair; poor venous access; history of gastric surgery or malabsorption disorders; any clinically significant cardiac abnormalities/dysfunction that may interfere with participant treatment, assessment, or compliance; any major medical condition which might interfere with participant treatment, assessment, or compliance; history of a medical/surgical condition that resulted in hospitalization within the 3 months prior to enrollment; medical/surgical conditions that may result in a need for hospitalization during the study duration; any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor antagonists, or immunosuppressant drugs; life-threatening serious adverse event (SAE) during the screening period; history of chronic hepatitis not caused by HCV.
  • If female has a positive urine pregnancy test within 24 hours before the first dose of study treatment.
  • Is taking or plans to take prohibited medications, or is taking herbal supplements.
  • Has had previous HCV direct acting antiviral (DAA) treatment.
  • Is currently participating or has participated in a study with an investigational compound within prior 30 days
  • Has significant emotional problems or a clinically significant psychiatric disorder that may interfere with participant treatment, assessment, or compliance with the protocol.
  • Has clinically relevant drug or alcohol abuse within prior 12 months that may interfere with participant treatment, assessment, or compliance.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    EBR/GZR

    Pediatric participants receive EBR/GZR as either FDC tablets or oral granules once daily for 12 weeks. A 24-week follow-up period will follow the 12-week treatment regimen.

    Drug: EBR/GZR FDC Tablet · Drug: Placebo · Drug: Grazoprevir Oral Granules · Drug: Elbasvir Oral Granules

Interventions

  • DrugEBR/GZR FDC Tablet

    Participants who are 12 to \<18 years of age will receive oral FDC tablets with EBR 50 mg/GZR 100 mg once daily by mouth.

    Also known as: MK-5172A, ZEPATIER®

  • DrugPlacebo

    Placebo tablet matched to EBR/GZR FDC tablet.

  • DrugGrazoprevir Oral Granules

    Participants 3 to \<12 years of age take grazoprevir granules 0.5 mg by mouth in a soft food vehicle at a dose not to exceed 50 mg.

    Also known as: MK-5172

  • DrugElbasvir Oral Granules

    Participants 3 to \<12 years of age take elbasvir oral granules 1 mg by mouth in a soft food vehicle at a dose not to exceed 100 mg.

    Also known as: MK-8742

05

What researchers measure

Primary outcomes

  1. Area Under the Plasma Concentration-Time Curve From Dosing to 24 Hours Postdose (AUC0-24hr) of EBR at Steady State

    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

  2. Maximum Plasma Concentration (Cmax) of EBR

    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

  3. Steady State Predose Drug Concentration (Ctrough) of EBR

    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

  4. Apparent Clearance (CL/F) of EBR at Steady State

    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

  5. AUC0-24hr of GZR at Steady State

    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

  6. Cmax of GZR

    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

  7. Ctrough of GZR

    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

  8. CL/F of GZR at Steady State

    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

Secondary outcomes

  1. Percentage of Participants With ≥1 Adverse Event (AE)

    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 36 weeks

  2. Percentage of Participants Discontinuing Study Treatment Due to an AE

    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

  3. Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Treatment (SVR12)

    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

06

Results

Posted Aug 17, 2020

Participant flow

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.

Participant flow — Overall Study
MilestoneAge Cohort 1: 12 to <18 Years: Mini and ExpandedAge Cohort 2: 7 to <12 Years: Mini and ExpandedAge Cohort 3: 3 to <7 Years: MiniAge Cohort 3: 3 to <7 Years: Expanded
Started2217711
Completed2217711
Not completed0000

Outcome measures

PrimaryArea Under the Plasma Concentration-Time Curve From Dosing to 24 Hours Postdose (AUC0-24hr) of EBR at Steady State

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
Reported as:
Geometric mean · µM*hr
Area Under the Plasma Concentration-Time Curve From Dosing to 24 Hours Postdose (AUC0-24hr) of EBR at Steady State
µM*hrAge Cohort 1: 12 to <18 Years: Mini and ExpandedAge Cohort 2: 7 to <12 Years: Mini and ExpandedAge Cohort 3: 3 to <7 Years: MiniAge Cohort 3: 3 to <7 Years: Expanded
Area Under the Plasma Concentration-Time Curve From Dosing to 24 Hours Postdose (AUC0-24hr) of EBR at Steady State2.41 (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)
PrimaryMaximum Plasma Concentration (Cmax) of EBR

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
Reported as:
Geometric mean · µM
Maximum Plasma Concentration (Cmax) of EBR
µMAge Cohort 1: 12 to <18 Years: Mini and ExpandedAge Cohort 2: 7 to <12 Years: Mini and ExpandedAge Cohort 3: 3 to <7 Years: MiniAge Cohort 3: 3 to <7 Years: Expanded
Maximum Plasma Concentration (Cmax) of EBR0.19 (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)
PrimarySteady State Predose Drug Concentration (Ctrough) of EBR

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
Reported as:
Geometric mean · nM
Steady State Predose Drug Concentration (Ctrough) of EBR
nMAge Cohort 1: 12 to <18 Years: Mini and ExpandedAge Cohort 2: 7 to <12 Years: Mini and ExpandedAge Cohort 3: 3 to <7 Years: MiniAge Cohort 3: 3 to <7 Years: Expanded
Steady State Predose Drug Concentration (Ctrough) of EBR59.76 (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)
PrimaryApparent Clearance (CL/F) of EBR at Steady State

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
Reported as:
Geometric mean · L/hr
Apparent Clearance (CL/F) of EBR at Steady State
L/hrAge Cohort 1: 12 to <18 Years: Mini and ExpandedAge Cohort 2: 7 to <12 Years: Mini and ExpandedAge Cohort 3: 3 to <7 Years: MiniAge Cohort 3: 3 to <7 Years: Expanded
Apparent Clearance (CL/F) of EBR at Steady State23.53 (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)
SecondaryPercentage of Participants With ≥1 Adverse Event (AE)

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 36 weeks
Reported as:
Number · Percentage of Participants
Percentage of Participants With ≥1 Adverse Event (AE)
Percentage of ParticipantsAge Cohort 1: 12 to <18 Years: Mini and ExpandedAge Cohort 2: 7 to <12 Years: Mini and ExpandedAge Cohort 3: 3 to <7 Years: MiniAge Cohort 3: 3 to <7 Years: Expanded
Percentage of Participants With ≥1 Adverse Event (AE)81.876.585.781.8
SecondaryPercentage of Participants Discontinuing Study Treatment Due to an AE

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
Reported as:
Number · Percentage of Participants
Percentage of Participants Discontinuing Study Treatment Due to an AE
Percentage of ParticipantsAge Cohort 1: 12 to <18 Years: Mini and ExpandedAge Cohort 2: 7 to <12 Years: Mini and ExpandedAge Cohort 3: 3 to <7 Years: MiniAge Cohort 3: 3 to <7 Years: Expanded
Percentage of Participants Discontinuing Study Treatment Due to an AE0.00.00.00.0
SecondaryPercentage of Participants With Sustained Virologic Response 12 Weeks After Completing Treatment (SVR12)

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
Reported as:
Number · Percentage of Participants
Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Treatment (SVR12)
Percentage of ParticipantsAge Cohort 1: 12 to <18 Years: Mini and ExpandedAge Cohort 2: 7 to <12 Years: Mini and ExpandedAge Cohort 3: 3 to <7 Years: MiniAge Cohort 3: 3 to <7 Years: Expanded
Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Treatment (SVR12)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)
PrimaryAUC0-24hr of GZR at Steady State

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
Reported as:
Geometric mean · µM*hr
AUC0-24hr of GZR at Steady State
µM*hrAge Cohort 1: 12 to <18 Years: Mini and ExpandedAge Cohort 2: 7 to <12 Years: Mini and ExpandedAge Cohort 3: 3 to <7 Years: MiniAge Cohort 3: 3 to <7 Years: Expanded
AUC0-24hr of GZR at Steady State1.45 (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)
PrimaryCmax of GZR

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
Reported as:
Geometric mean · µM
Cmax of GZR
µMAge Cohort 1: 12 to <18 Years: Mini and ExpandedAge Cohort 2: 7 to <12 Years: Mini and ExpandedAge Cohort 3: 3 to <7 Years: MiniAge Cohort 3: 3 to <7 Years: Expanded
Cmax of GZR0.25 (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)
PrimaryCtrough of GZR

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
Reported as:
Geometric mean · nM
Ctrough of GZR
nMAge Cohort 1: 12 to <18 Years: Mini and ExpandedAge Cohort 2: 7 to <12 Years: Mini and ExpandedAge Cohort 3: 3 to <7 Years: MiniAge Cohort 3: 3 to <7 Years: Expanded
Ctrough of GZR16.20 (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)
PrimaryCL/F of GZR at Steady State

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

No measurements were reported for this outcome.

Adverse events

Collected over Up to 36 weeks for nonserious AEs (NSAEs) and serious AEs (SAEs), and up to approximately 49 weeks for all-cause mortality.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Age Cohort 1: 12 to < 18 Years0/22 (0%)1/22 (4.5%)17/22 (77.3%)
Age Cohort 2: 7 to < 12 Years0/17 (0%)0/17 (0%)13/17 (76.5%)
Age Cohort 3 Mini: 3 to < 7 Years0/7 (0%)0/7 (0%)6/7 (85.7%)
Age Cohort 3 Expanded: 3 to < 7 Years0/11 (0%)1/11 (9.1%)9/11 (81.8%)
Most frequent serious events
Most frequent serious events
EventAge Cohort 1: 12 to < 18 YearsAge Cohort 2: 7 to < 12 YearsAge Cohort 3 Mini: 3 to < 7 YearsAge Cohort 3 Expanded: 3 to < 7 Years
DyspepsiaGastrointestinal disorders0/220/170/71/11
Hand fractureInjury, poisoning and procedural complications1/220/170/70/11
Most frequent other events
Showing 10 of 56
Most frequent other events
EventAge Cohort 1: 12 to < 18 YearsAge Cohort 2: 7 to < 12 YearsAge Cohort 3 Mini: 3 to < 7 YearsAge Cohort 3 Expanded: 3 to < 7 Years
HeadacheNervous system disorders8/222/170/72/11
VomitingGastrointestinal disorders3/221/170/73/11
Respiratory tract infectionInfections and infestations0/222/171/73/11
Upper respiratory tract infectionInfections and infestations0/223/171/73/11
ConstipationGastrointestinal disorders1/220/171/72/11
NauseaGastrointestinal disorders4/220/170/70/11
BronchitisInfections and infestations0/220/171/72/11
NasopharyngitisInfections and infestations4/221/171/71/11
Abdominal painGastrointestinal disorders1/221/171/70/11
DiarrhoeaGastrointestinal disorders1/221/171/70/11

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Age Cohort 1: 12 to <18 Years: Mini and ExpandedAge Cohort 2: 7 to <12 Years: Mini and ExpandedAge Cohort 3: 3 to <7 Years: MiniAge Cohort 3: 3 to <7 Years: ExpandedTotal
Mean14.1 ± 1.98.7 ± 1.23.7 ± 0.84.8 ± 1.39.4 ± 4.4
Sex: Female, Male
Sex: Female, Male(Participants)Age Cohort 1: 12 to <18 Years: Mini and ExpandedAge Cohort 2: 7 to <12 Years: Mini and ExpandedAge Cohort 3: 3 to <7 Years: MiniAge Cohort 3: 3 to <7 Years: ExpandedTotal
Female1173829
Male11104328
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Age Cohort 1: 12 to <18 Years: Mini and ExpandedAge Cohort 2: 7 to <12 Years: Mini and ExpandedAge Cohort 3: 3 to <7 Years: MiniAge Cohort 3: 3 to <7 Years: ExpandedTotal
Hispanic or Latino32106
Not Hispanic or Latino191461150
Unknown or Not Reported01001
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Age Cohort 1: 12 to <18 Years: Mini and ExpandedAge Cohort 2: 7 to <12 Years: Mini and ExpandedAge Cohort 3: 3 to <7 Years: MiniAge Cohort 3: 3 to <7 Years: ExpandedTotal
American Indian or Alaska Native00000
Asian00000
Native Hawaiian or Other Pacific Islander00000
Black or African American00000
White211771156
More than one race10001
Unknown or Not Reported00000
07

Study locations

15 sites
  • University of California San Francisco ( Site 0020)
    San Francisco, California 94158, United States
  • Florida Hospital ( Site 0006)
    Orlando, Florida 32803, United States
  • Children's Center for Advanced Pediatrics ( Site 0204)
    Atlanta, Georgia 30329, United States
  • Children's Hospital Boston ( Site 0009)
    Boston, Massachusetts 02115, United States
  • Cincinnati Children's Hospital Medical Center ( Site 0003)
    Cincinnati, Ohio 45229, United States
  • Children's Hospital of Pittsburgh ( Site 0024)
    Pittsburgh, Pennsylvania 15224, United States
  • American Research Corporation ( Site 0200)
    San Antonio, Texas 78215, United States
  • Children's Hospital and Regional Medical Center ( Site 0017)
    Seattle, Washington 98105, United States
  • Medizinische Hochschule Hannover Kinderklinik K10 ( Site 0105)
    Hannover, 30625, Germany
  • Klinikum Starnberg ( Site 0107)
    Starnberg, 82319, Germany
  • Helios Klinikum Wuppertal GmbH ( Site 0104)
    Wuppertal, 42283, Germany
  • WSOZ im.T.Browicza w Bydgoszczy ( Site 0800)
    Bydgoszcz, 85-030, Poland
  • Wojewodzki Specjalistyczny Szpital im. dr W. Bieganskiego w Lodzi ( Site 0810)
    Lodz, 91-347, Poland
  • MED-POLONIA Sp. z o.o. ( Site 0808)
    Poznan, 60-693, Poland
  • Karolinska Universitetssjukhuset Huddinge. ( Site 0062)
    Stockholm, 141 86, Sweden
08

References and documents

Publications

  • Gonzalez-Peralta RP, Wirth S, Squires RH, Mutschler F, Lang T, Pawlowska M, Sluzewski W, Majda-Stanislawska E, Fischler B, Balistreri WF, Jonas MM, Blondet N, Rosenthal P, Alkhouri N, Romero R, Grandhi A, Castronuovo P, Caro L, Du L, Rosenbloom DIS, Haber BA. Elbasvir/grazoprevir in children aged 3-18 years with chronic HCV genotype 1 or 4 infection: a pharmacokinetic modeling study. Hepatol Commun. 2023 Feb 14;7(3):e0031. doi: 10.1097/HC9.0000000000000031. eCollection 2023 Mar 1. PubMed 36790337 ↗

Study documents

  • Protocol and statistical analysis plan · Feb 16, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

09

Registry details

Key details

Study ID
NCT03379506
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Dec 20, 2017
Start date
Jan 25, 2018
Primary completion
Oct 28, 2019
Completion
Jul 23, 2020
Results posted
Aug 17, 2020
Last update
May 31, 2023

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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