Hepatitis C Virus (HCV) InfectionPhase 4NCT03111108

Efficacy and Safety of Elbasvir (MK-8742) + Grazoprevir (MK-5172) in Treatment-Naïve/Treatment-Experienced (TN/TE) French Participants With Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection (MK-5172-096)

A Phase 4 study testing EBR/GZR (50 mg/100 mg) FDC in people with Hepatitis C Virus (HCV) Infection, run by Merck Sharp & Dohme LLC at 13 sites in France.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C Virus (HCV) Infection
What is being tested?: EBR/GZR (50 mg/100 mg) FDC
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 117 participants
Where: 13 sitesFrance
Study dates: 20 Jun 2017to 15 Oct 2018
Phase: Phase 4
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be a current resident of France
Have HCV RNA (≥ 10,000 IU/mL in peripheral blood) at the time of screening
Have documented chronic HCV GT4 (with no evidence of non-typeable or mixed genotype) infection
Have liver biopsy performed within 24 months of Day 1 of this study (if participant has cirrhosis, there is no time restriction on biopsy), or have FibroScan® performed within 12 months of Day 1 of this study with interpretable result in kilopascals (kPa) as follows: Fibrosis score of F0-F2, Fibrosis score of F3, or Cirrhosis (F4)
Have a prior treatment history of either HCV TN or HCV TE with interferon (IFN) +/- ribavirin (RBV) +/- Sofosbuvir (SOF) (on-treatment failure, relapser, or other/intolerant)
Females who are of reproductive potential must agree to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug by complying with one of the following: (1) practice abstinence from heterosexual activity OR (2) use (or have her partner use) acceptable contraception during heterosexual activity
If Human Immunodeficiency Virus (HIV) co-infected, then have HIV-1 infection documented prior to screening

Who cannot join

Had prior treatment (defined as 1 dose or more) with direct-acting antiviral (DAA) therapy
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 active advanced liver disease
Classified as Child-Pugh B or C or has a Child Pugh-Turcotte score (CPT) > 6
Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
Hepatitis B virus surface antigen (HBsAg) positive at screening. Participants who are HBsAg negative and hepatitis B core antibody (anti-HBc) positive at screening may be included
Under evaluation for active or suspected malignancy, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer Currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

France13 sites

CHU Amiens-Picardie - Hopital Sud ( Site 0217)
Amiens
CHU Jean Minjoz ( Site 0213)
Besançon
CHU Henri Mondor ( Site 0206)
Créteil
CHU de Grenoble - Hopital Michallon ( Site 0208)
Genoble
CHU Dupuytren ( Site 0209)
Limoges
Hopital Saint Eloi ( Site 0207)
Montpellier
C.H.U. de Nice Hopital de l Archet 2 ( Site 0215)
Nice
Centre Hospitalier Regional du Orleans ( Site 0212)
Orléans
Hopital Beaujon ( Site 0201)
Paris
Hopital Cochin ( Site 0211)
Paris
Hopital Saint Antoine ( Site 0200)
Paris
CHU de Toulouse - Hopital Purpan ( Site 0216)
Toulouse
CHU de Nancy Hopital Brabois Adultes ( Site 0204)
Vandœuvre-lès-Nancy

Other trials in France

About this study

Official title: A Multi-Site, Open-Label, Partially-Randomized Trial of the Efficacy and Safety of Fixed Dose Elbasvir/Grazoprevir (EBR/GZR) Based Regimens in French Subjects With Chronic Hepatitis C Virus (HCV) Genotype 4 Infection

The purpose of this study was to evaluate the efficacy of 8 and 12 weeks of treatment with a fixed dose combination (FDC) of elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg (i.e., MK-5172A) as assessed by the percentage of participants with hepatitis C virus (HCV) genotype (GT) 4 infection that achieve sustained virologic response (HCV ribonucleic acid [RNA] < Lower Limit of Quantification [LLOQ]) 12 weeks after the end of study therapy (SVR12). This study also evaluated the safety and tolerability of EBR/GZR.

Conditions: Hepatitis C Virus (HCV) Infection
Being tested: EBR/GZR (50 mg/100 mg) FDC
Medical subject headings: Hepatitis C, Infections

What participants receive

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

EBR/GZR (50 mg/100 mg) FDCDrug
Also called MK-5172A
One FDC tablet taken once daily by mouth for 8 or 12 weeks depending upon randomization.

Study groups in NCT03111108
Study group	Role	What they receive
Arm 1: EBR/GZR for 8 Weeks	Experimental	Treatment-naïve participants with stage 0-2 fibrosis (F0-F2) receive FDC of EBR/GZR (50 mg/100 mg) for 8 weeks, with 24 weeks of follow-up. Receives: Drug: EBR/GZR (50 mg/100 mg) FDC
Arm 2: EBR/GZR for 12 Weeks	Experimental	Treatment-naïve participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis receive FDC of EBR/GZR (50 mg/100 mg) for 12 weeks, with 24 weeks of follow-up. Receives: Drug: EBR/GZR (50 mg/100 mg) FDC

What is being measured

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

Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After End of Treatment (SVR12)
The percentage of participants to achieve SVR12 was determined for each arm (SVR12 was defined as HCV ribonucleic acid [RNA] < lower limit of quantification [LLOQ] at 12 weeks after the end of all study therapy). Plasma HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ TaqMan HCV Test, v2.0®, which has a LLOQ of 15 IU/mL.
Measured: 12 weeks after completing study treatment (Arm 1: Week 20 / Arm 2: Week 24)
Number of Participants With ≥ 1 Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to 14 weeks
Number of Participants Who Discontinued From Study Treatment Due to an AE
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to Study Week 12

Secondary outcomes (3)

Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After End of Treatment (SVR24)
The percentage of participants to achieve SVR24 was determined for each arm (SVR24 was defined as HCV RNA < LLOQ at 24 weeks after the end of all study therapy). Plasma HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ TaqMan HCV Test, v2.0®, which has a LLOQ of 15 IU/mL.
Measured: 24 weeks after completing study treatment (Arm 1: Week 32 / Arm 2: Week 36)
Prevalence of Baseline NS3 Resistance-Associated Substitutions (RASs) to EBR or GZR
Blood samples for viral resistance assays were collected at Baseline (Day 1) and analyzed for substitutions in the NS3 gene region. Results are pooled for all participants with baseline sequencing data available, and the number of participants with RASs is reported according HCV genotype. Resistance-associated substitutions are defined as amino acid substitutions that confer reduced susceptibility to a direct-acting antiviral (DAA) and may contribute to virologic failure. The prevalence of baseline substitutions in participants infected with HCV GT4 subtypes was assessed by evaluating amino acid substitutions in NS3.
Measured: Day 1
Prevalence of Baseline NS5A RASs to EBR or GZR
Blood samples for viral resistance assays were collected at Baseline (Day 1) and analyzed for substitutions in the NS5A gene region. Results are pooled for all participants with baseline sequencing data available, and the number of participants with RASs is reported according HCV genotype. Resistance-associated substitutions are defined as amino acid substitutions that confer reduced susceptibility to a DAA and may contribute to virologic failure. The prevalence of baseline substitutions in participants infected with HCV GT4 subtypes was assessed by evaluating amino acid substitutions in NS5A.
Measured: Day 1

Timeline

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

20 Jun 201715 Oct 2018

First posted12 Apr 2017
Study start20 Jun 2017
Primary completion15 Oct 2018
Study completion15 Oct 2018

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 Hepatitis C Virus (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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03111108
Sponsor's protocol ID: 5172-096
Other IDs: 2016-001159-37, MK-5172-096, 2016
Status last verified: May 2020
First submitted: 6 Apr 2017
Last updated: 9 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Asselah T, Pol S, Hezode C, Loustaud-Ratti V, Leroy V, Ahmed SNS, Ozenne V, Bronowicki JP, Larrey D, Tran A, Alric L, Nguyen-Khac E, Robertson MN, Hanna GJ, Brown D, Asante-Appiah E, Su FH, Hwang P, Hall JD, Guidoum A, Hagen K, Haber BA, Talwani R, Serfaty L. Efficacy and safety of elbasvir/grazoprevir for 8 or 12 weeks for hepatitis C virus genotype 4 infection: A randomized study. Liver Int. 2020 May;40(5):1042-1051. doi: 10.1111/liv.14313. Epub 2020 Mar 22.
PubMed 31765046

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 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Site, Open-Label, Partially-Randomized Trial of the Efficacy and Safety of Fixed Dose Elbasvir/Grazoprevir (EBR/GZR) Based Regimens in French Subjects With Chronic Hepatitis C Virus (HCV) Genotype 4 Infection
ClinicalTrials.gov ID: NCT03111108
Acronym / sponsor ID: 5172-096
Conditions: Hepatitis C Virus (HCV) Infection
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 20 Jun 2017 (actual)
Primary completion: 15 Oct 2018 (actual)
Study completion: 15 Oct 2018 (actual)
First posted: 12 Apr 2017 (actual)
Results: Posted 12 Nov 2019

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1: EBR/GZR for 8 Weeks	Experimental	Drug: EBR/GZR (50 mg/100 mg) FDCTreatment-naïve participants with stage 0-2 fibrosis (F0-F2) receive FDC of EBR/GZR (50 mg/100 mg) for 8 weeks, with 24 weeks of follow-up.
Arm 2: EBR/GZR for 12 Weeks	Experimental	Drug: EBR/GZR (50 mg/100 mg) FDCTreatment-naïve participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis receive FDC of EBR/GZR (50 mg/100 mg) for 12 weeks, with 24 weeks of follow-up.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Be a current resident of France
Have HCV RNA (≥ 10,000 IU/mL in peripheral blood) at the time of screening
Have documented chronic HCV GT4 (with no evidence of non-typeable or mixed genotype) infection
Have liver biopsy performed within 24 months of Day 1 of this study (if participant has cirrhosis, there is no time restriction on biopsy), or have FibroScan® performed within 12 months of Day 1 of this study with interpretable result in kilopascals (kPa) as follows: Fibrosis score of F0-F2, Fibrosis score of F3, or Cirrhosis (F4)
Have a prior treatment history of either HCV TN or HCV TE with interferon (IFN) +/- ribavirin (RBV) +/- Sofosbuvir (SOF) (on-treatment failure, relapser, or other/intolerant)

Key exclusion criteria (6 listed)

Had prior treatment (defined as 1 dose or more) with direct-acting antiviral (DAA) therapy
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 active advanced liver disease
Classified as Child-Pugh B or C or has a Child Pugh-Turcotte score (CPT) > 6
Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
Hepatitis B virus surface antigen (HBsAg) positive at screening. Participants who are HBsAg negative and hepatitis B core antibody (anti-HBc) positive at screening may be included

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 (50 mg/100 mg) FDCAlso: MK-5172AOne FDC tablet taken once daily by mouth for 8 or 12 weeks depending upon randomization.	Drug	Arm 1: EBR/GZR for 8 Weeks, Arm 2: EBR/GZR for 12 Weeks

Primary outcome

Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After End of Treatment (SVR12)
Time frame: 12 weeks after completing study treatment (Arm 1: Week 20 / Arm 2: Week 24)
The percentage of participants to achieve SVR12 was determined for each arm (SVR12 was defined as HCV ribonucleic acid [RNA] < lower limit of quantification [LLOQ] at 12 weeks after the end of all study therapy). Plasma HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ TaqMan HCV Test, v2.0®, which has a LLOQ of 15 IU/mL.
Number of Participants With ≥ 1 Adverse Events (AEs)
Time frame: Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Number of Participants Who Discontinued From Study Treatment Due to an AE
Time frame: Up to Study Week 12
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

3 secondary outcomes

Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After End of Treatment (SVR24)
Time frame: 24 weeks after completing study treatment (Arm 1: Week 32 / Arm 2: Week 36)
Prevalence of Baseline NS3 Resistance-Associated Substitutions (RASs) to EBR or GZR
Time frame: Day 1
Prevalence of Baseline NS5A RASs to EBR or GZR
Time frame: Day 1

Results and safety

Results posted to the registry on 12 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: EBR/GZR for 8 Weeks	53	52
Arm 2: EBR/GZR for 12 Weeks	64	63

Primary outcome: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After End of Treatment (SVR12)

Time frame: 12 weeks after completing study treatment (Arm 1: Week 20 / Arm 2: Week 24). Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Arm 1: EBR/GZR for 8 Weeks n = 53	Arm 2: EBR/GZR for 12 Weeks n = 64
Value	94.3 (84.3 to 98.8)	95.3 (86.9 to 99.0)

Population analysed: All randomized participants who received ≥1 dose of study treatment are included.

Primary outcome: Number of Participants With ≥ 1 Adverse Events (AEs)

Time frame: Up to 14 weeks. Number. Unit: Participants

Measure	Arm 1: EBR/GZR for 8 Weeks n = 53	Arm 2: EBR/GZR for 12 Weeks n = 64
Value	33	46

Population analysed: All randomized participants who received ≥1 dose of study treatment are included, classified according to treatment duration actually received.

Primary outcome: Number of Participants Who Discontinued From Study Treatment Due to an AE

Time frame: Up to Study Week 12. Number. Unit: Participants

Measure	Arm 1: EBR/GZR for 8 Weeks n = 53	Arm 2: EBR/GZR for 12 Weeks n = 64
Value	0	0

Population analysed: All randomized participants who received ≥1 dose of study treatment are included, classified according to treatment duration actually received.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 36 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: EBR/GZR for 8 Weeks	2 of 53 (3.8%)	27 of 53 (50.9%)	0 of 53
Arm 2: EBR/GZR for 12 Weeks	2 of 64 (3.1%)	38 of 64 (59.4%)	1 of 64

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31765046Asselah T, Pol S, Hezode C, Loustaud-Ratti V, Leroy V, Ahmed SNS, Ozenne V, Bronowicki JP, Larrey D, Tran A, Alric L, Nguyen-Khac E, Robertson MN, Hanna GJ, Brown D, Asante-Appiah E, Su FH, Hwang P, Hall JD, Guidoum A, Hagen K, Haber BA, Talwani R, Serfaty L. Efficacy and safety of elbasvir/grazoprevir for 8 or 12 weeks for hepatitis C virus genotype 4 infection: A randomized study. Liver Int. 2020 May;40(5):1042-1051. doi: 10.1111/liv.14313. Epub 2020 Mar 22.
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

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing EBR/GZR (50 mg/100 mg) FDC in people with Hepatitis C Virus (HCV) Infection, run by Merck Sharp & Dohme LLC at 13 sites in France.

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 7 inclusion and 6 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 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 12 Nov 2019). 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?

Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After End of Treatment (SVR12) (time frame: 12 weeks after completing study treatment (Arm 1: Week 20 / Arm 2: Week 24)). The study lists 3 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 NCT03111108, 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 9 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.