HCV InfectionPhase 2NCT03379506

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

A Phase 2 study testing EBR/GZR FDC Tablet, Grazoprevir Oral Granules and Elbasvir Oral Granules in people with HCV Infection, run by Merck Sharp & Dohme LLC at 15 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 3 to 17 years
Conditions the study is for: HCV Infection
What is being tested?: EBR/GZR FDC Tablet, Grazoprevir Oral Granules and Elbasvir Oral Granules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: 15 sitesin 4 countries
Study dates: 25 Jan 2018to 23 Jul 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Show all 13Show fewer

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.

Trial locations and contacts

15 sites in 4 countries.

Country

City, postcode or hospital

15 sites in 4 countries

United States8 sites

Children's Center for Advanced Pediatrics ( Site 0204)
Atlanta, Georgia, 30329
Children's Hospital Boston ( Site 0009)
Boston, Massachusetts, 02115
Cincinnati Children's Hospital Medical Center ( Site 0003)
Cincinnati, Ohio, 45229
Florida Hospital ( Site 0006)
Orlando, Florida, 32803
Children's Hospital of Pittsburgh ( Site 0024)
Pittsburgh, Pennsylvania, 15224
American Research Corporation ( Site 0200)
San Antonio, Texas, 78215
University of California San Francisco ( Site 0020)
San Francisco, California, 94158
Children's Hospital and Regional Medical Center ( Site 0017)
Seattle, Washington, 98105

Other trials in United States

Germany3 sites

Medizinische Hochschule Hannover Kinderklinik K10 ( Site 0105)
Hanover, 30625
Klinikum Starnberg ( Site 0107)
Starnberg, 82319
Helios Klinikum Wuppertal GmbH ( Site 0104)
Wuppertal, 42283

Other trials in Germany

Poland3 sites

WSOZ im.T.Browicza w Bydgoszczy ( Site 0800)
Bydgoszcz, 85-030
Wojewodzki Specjalistyczny Szpital im. dr W. Bieganskiego w Lodzi ( Site 0810)
Lodz, 91-347
MED-POLONIA Sp. z o.o. ( Site 0808)
Poznan, 60-693

Other trials in Poland

Sweden1 site

Karolinska Universitetssjukhuset Huddinge. ( Site 0062)
Stockholm, 141 86

Other trials in Sweden

About this study

Official title: A Phase IIb Clinical Study to Assess the Pharmacokinetics, Safety, and Efficacy of the Combination Regimen of Elbasvir (EBR)/Grazoprevir (GZR) in Participants Aged 3 to Less Than 18 Years With Chronic Hepatitis C Infection

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.

Conditions: HCV Infection
Being tested: EBR/GZR FDC Tablet, Placebo, Grazoprevir Oral Granules, Elbasvir Oral Granules
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EBR/GZR FDC TabletDrug
Also called MK-5172A, ZEPATIER®
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.
PlaceboDrug
Placebo tablet matched to EBR/GZR FDC tablet.
Grazoprevir Oral GranulesDrug
Also called MK-5172
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.
Elbasvir Oral GranulesDrug
Also called MK-8742
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.

Study groups in NCT03379506
Study group	Role	What they receive
EBR/GZR	Experimental	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. Receives: Drug: EBR/GZR FDC Tablet; Drug: Placebo; Drug: Grazoprevir Oral Granules; Drug: Elbasvir Oral Granules

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Maximum Plasma Concentration (Cmax) of EBR
The Cmax of EBR at steady state (Week 4) was determined in each cohort.
Measured: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
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.
Measured: Week 4: Predose
Apparent Clearance (CL/F) of EBR at Steady State
The CL/F of EBR at steady state (Week 4) was determined in each cohort.
Measured: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
AUC0-24hr of GZR at Steady State
The AUC0-24hr of GZR at steady state (Week 4) was determined in each cohort.
Measured: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Cmax of GZR
The Cmax of GZR at steady state (Week 4) was determined in each cohort.
Measured: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Ctrough of GZR
The Ctrough of GZR at steady state (Week 4) was determined at steady state prior to dosing in each cohort.
Measured: Week 4: Predose
CL/F of GZR at Steady State
The CL/F of GZR at steady state (Week 4) was determined in each cohort.
Measured: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose

Secondary outcomes (3)

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.
Measured: Up to 36 weeks
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.
Measured: Up to 12 weeks
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.
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jan 201823 Jul 2020

First posted20 Dec 2017
Study start25 Jan 2018
Primary completion28 Oct 2019
Study completion23 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HCV InfectionStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03379506
Sponsor's protocol ID: 5172-079
Other IDs: MK-5172-079, 2015-003006-16, 2015
Status last verified: May 2023
First submitted: 13 Dec 2017
Last updated: 31 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb Clinical Study to Assess the Pharmacokinetics, Safety, and Efficacy of the Combination Regimen of Elbasvir (EBR)/Grazoprevir (GZR) in Participants Aged 3 to Less Than 18 Years With Chronic Hepatitis C Infection
ClinicalTrials.gov ID: NCT03379506
Acronym / sponsor ID: 5172-079
Conditions: HCV Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 25 Jan 2018 (actual)
Primary completion: 28 Oct 2019 (actual)
Study completion: 23 Jul 2020 (actual)
First posted: 20 Dec 2017 (actual)
Results: Posted 17 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
EBR/GZR	Experimental	Drug: EBR/GZR FDC Tablet, Drug: Placebo, Drug: Grazoprevir Oral Granules, Drug: Elbasvir Oral GranulesPediatric 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.

Who may qualify

Ages: 3 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EBR/GZR FDC TabletAlso: MK-5172A, ZEPATIER®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.	Drug	EBR/GZR
PlaceboPlacebo tablet matched to EBR/GZR FDC tablet.	Drug	EBR/GZR
Grazoprevir Oral GranulesAlso: MK-5172Participants 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.	Drug	EBR/GZR
Elbasvir Oral GranulesAlso: MK-8742Participants 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.	Drug	EBR/GZR

Primary outcome

Area Under the Plasma Concentration-Time Curve From Dosing to 24 Hours Postdose (AUC0-24hr) of EBR at Steady State
Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
The AUC0-24hr of EBR at steady state (Week 4) was determined in each cohort.
Maximum Plasma Concentration (Cmax) of EBR
Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
The Cmax of EBR at steady state (Week 4) was determined in each cohort.
Steady State Predose Drug Concentration (Ctrough) of EBR
Time frame: Week 4: Predose
The Ctrough of EBR at steady state (Week 4) was determined at steady state prior to dosing in each cohort.
Apparent Clearance (CL/F) of EBR at Steady State
Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
The CL/F of EBR at steady state (Week 4) was determined in each cohort.
AUC0-24hr of GZR at Steady State
Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
The AUC0-24hr of GZR at steady state (Week 4) was determined in each cohort.
Cmax of GZR
Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
The Cmax of GZR at steady state (Week 4) was determined in each cohort.
Ctrough of GZR
Time frame: Week 4: Predose
The Ctrough of GZR at steady state (Week 4) was determined at steady state prior to dosing in each cohort.
CL/F of GZR at Steady State
Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
The CL/F of GZR at steady state (Week 4) was determined in each cohort.

3 secondary outcomes

Percentage of Participants With ≥1 Adverse Event (AE)
Time frame: Up to 36 weeks
Percentage of Participants Discontinuing Study Treatment Due to an AE
Time frame: Up to 12 weeks
Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Treatment (SVR12)
Time frame: Week 24

Results and safety

Results posted to the registry on 17 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Age Cohort 1: 12 to <18 Years: Mini and Expanded	22	22
Age Cohort 2: 7 to <12 Years: Mini and Expanded	17	17
Age Cohort 3: 3 to <7 Years: Mini	7	7
Age Cohort 3: 3 to <7 Years: Expanded	11	11

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

Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose. Geometric mean (95% Confidence Interval). Unit: µM*hr

Measure	Age Cohort 1: 12 to <18 Years: Mini and Expanded n = 22	Age Cohort 2: 7 to <12 Years: Mini and Expanded n = 17	Age Cohort 3: 3 to <7 Years: Mini n = 7	Age Cohort 3: 3 to <7 Years: Expanded n = 11
Value	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)

Population analysed: 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.

Primary outcome: Maximum Plasma Concentration (Cmax) of EBR

Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose. Geometric mean (95% Confidence Interval). Unit: µM

Measure	Age Cohort 1: 12 to <18 Years: Mini and Expanded n = 22	Age Cohort 2: 7 to <12 Years: Mini and Expanded n = 17	Age Cohort 3: 3 to <7 Years: Mini n = 7	Age Cohort 3: 3 to <7 Years: Expanded n = 11
Value	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)

Population analysed: 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.

Primary outcome: Steady State Predose Drug Concentration (Ctrough) of EBR

Time frame: Week 4: Predose. Geometric mean (95% Confidence Interval). Unit: nM

Measure	Age Cohort 1: 12 to <18 Years: Mini and Expanded n = 22	Age Cohort 2: 7 to <12 Years: Mini and Expanded n = 16	Age Cohort 3: 3 to <7 Years: Mini n = 7	Age Cohort 3: 3 to <7 Years: Expanded n = 11
Value	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)

Primary outcome: Apparent Clearance (CL/F) of EBR at Steady State

Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose. Geometric mean (95% Confidence Interval). Unit: L/hr

Measure	Age Cohort 1: 12 to <18 Years: Mini and Expanded n = 22	Age Cohort 2: 7 to <12 Years: Mini and Expanded n = 17	Age Cohort 3: 3 to <7 Years: Mini n = 7	Age Cohort 3: 3 to <7 Years: Expanded n = 11
Value	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)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 36 weeks for nonserious AEs (NSAEs) and serious AEs (SAEs), and up to approximately 49 weeks for all-cause mortality.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Age Cohort 1: 12 to < 18 Years	1 of 22 (4.5%)	17 of 22 (77.3%)	0 of 22
Age Cohort 2: 7 to < 12 Years	0 of 17 (0%)	13 of 17 (76.5%)	0 of 17
Age Cohort 3 Mini: 3 to < 7 Years	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7
Age Cohort 3 Expanded: 3 to < 7 Years	1 of 11 (9.1%)	9 of 11 (81.8%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 36790337Gonzalez-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.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

15 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EBR/GZR FDC Tablet, Grazoprevir Oral Granules and Elbasvir Oral Granules in people with HCV Infection, run by Merck Sharp & Dohme LLC at 15 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Germany, Poland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Plasma Concentration-Time Curve From Dosing to 24 Hours Postdose (AUC0-24hr) of EBR at Steady State (time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03379506, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.