Hepatitis CPhase 4NCT03143998
Efficacy and Safety of Elbasvir/Grazoprevir in Brazilian Participants With Chronic Hepatitis C Virus (HCV) Genotype 1 Infection With Advanced Fibrosis (F3 and F4)
A Phase 4 study testing MK-5172A in people with Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
This is a non-randomized, open-label study of a fixed dose combination (FDC) of elbasvir (50 mg) and grazoprevir (100 mg) (EBR/GZR or MK-5172A) in participants with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection with advanced fibrosis with and without human immunodeficiency virus (HIV) co-infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- MK-5172A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 12 Feb 2018to 12 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Adult (≥ 18 years of age) male and female participants with chronic HCV GT1 infection who reside in Brazil
- HCV RNA (≥ 10,000 IU/mL in peripheral blood) at the time of screening
- Has documented chronic HCV GT1 (1a; 1b) infection (with no evidence of non-typeable or mixed genotype) infection.
- positive for anti HCV antibody, HCV RNA, or HCV GT1 at least 6 months before screening, or
- positive for anti-HCV antibody or HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of chronic hepatitis C (CHC) disease, such as the presence of fibrosis)
- Is otherwise healthy as determined by the medical history, physical examination, and clinical laboratory measurements at the time of screening
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- Has a history of advanced fibrosis (F3 or F4) as follows:
- F4: FibroSure®/APRI + FibroTest®
- Liver biopsy result of METAVIR stage 3 or 4 fibrosis (or its grading system equivalency to advanced fibrosis)
- FibroScan® result > 9.5 kPa (F3 or F4)
- Has liver imaging within 6 months of Day 1 (start of treatment) with no evidence of hepatocellular carcinoma (HCC)
- Is TN or TE
- Is a male, is a female who is not of reproductive potential, or is a female of reproductive potential who agrees to avoid becoming pregnant from Day 1 (start of treatment) through 14 days after the last dose of study drug (or longer if dictated by local regulations)
- For HIV-infected participants, has HIV-1 infection documented prior to screening, and is either not currently on antiretroviral therapy (ART) and has no plans to initiate ART or has well-controlled HIV on ART as per study criteria
Who cannot join
- Has prior treatment with direct acting antiviral (DAA) therapy with the exception of boceprevir, telaprevir, and simeprevir
- Has evidence of decompensated liver disease as 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
- Is classified as Child-Pugh B or C or has a Child-Pugh-Turcotte score > 6
- Is hepatitis B surface antigen (HBsAg) positive at screening
- Is under evaluation for HCC or other active or suspected malignancy
- Is currently participating or has participated in a study with an investigational compound within 1 year of signing informed consent and is not willing to refrain from participating in another such study during the course of this study
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- Has clinically-relevant drug or alcohol abuse within 12 months of screening
- Is a female and is pregnant or breastfeeding, or expecting to conceive or donate eggs from Day 1 (start of treatment) through 14 days after the last dose of study drug or longer if dictated by local regulations; or is a male participant who is expecting to donate sperm from Day 1 (start of treatment) through 14 days after the last dose of study drug or longer if dictated by local regulations
- Has any clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol or any medical/surgical conditions that may result in a need for hospitalization during the period of the study; or is currently under evaluation for a potentially clinically-significant illness (other than HCV)
About this study
Official title: A Multi-Site, Open-Label, Trial of the Efficacy and Safety of Fixed-dose Elbasvir/Grazoprevir (EBR/GZR) in Brazilian Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 Infection With Advanced Fibrosis (F3 and F4)
This is a non-randomized, open-label study of a fixed dose combination (FDC) of elbasvir (50 mg) and grazoprevir (100 mg) (EBR/GZR or MK-5172A) in participants with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection with advanced fibrosis with and without human immunodeficiency virus (HIV) co-infection. All participants will be either HCV treatment naïve (TN) or treatment experienced (TE).
- Conditions
- Hepatitis C
- Being tested
- MK-5172A
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-5172ADrug
Also called ZEPATIER®
A single FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth.
| Study group | Role | What they receive |
|---|---|---|
| HCV GT1a TN | Experimental | Participants with HCV GT1a infection who are TN will take MK-5172A for 12 weeks. Receives: Drug: MK-5172A |
| HCV GT1a TE | Experimental | Participants with HCV GT1a infection who are TE will take MK-5172A for 12 weeks. Receives: Drug: MK-5172A |
| HCV GT1b TN | Experimental | Participants with HCV GT1b infection who are TN will take MK-5172A for 12 weeks. Receives: Drug: MK-5172A |
| HCV GT1b TE | Experimental | Participants with HCV GT1b infection who are TE will take MK-5172A for 12 weeks. Receives: Drug: MK-5172A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving sustained virologic response (SVR) 12 weeks after the end of all study therapy (SVR12)
SVR12 will be declared when a participant has HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the end of all study therapy. Levels of HCV RNA will be determined with the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0, which has a LLoQ of 15 IU/mL.
Measured: Week 24 (12 weeks after completing study therapy)
Percentage of participants experiencing an adverse event (AE)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to 14 weeks
Percentage of participants withdrawing from study therapy due to an AE
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to 12 weeks
Secondary outcomes (2)
Percentage of participants achieving SVR 24 weeks after the end of all study therapy (SVR24)
SVR24 will be declared when a participant has HCV RNA < LLOQ 24 weeks after the end of all study therapy. Levels of HCV RNA will be determined with the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0, which has a LLoQ of 15 IU/mL.
Measured: Week 36 (24 weeks after completing study therapy)
Emergence of viral resistance-associated variants (RAVs)
The RAVs resistant to EBR or GZR, including the association of baseline RAVs with treatment outcomes (SVR12 and SVR24) and the emergence of RAVs in participants who fail to achieve SVR will be determined.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start12 Feb 2018 (estimated)
- Primary completion12 Jan 2019 (estimated)
- Study completion12 Jan 2019 (estimated)
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143998
- Sponsor's protocol ID
- 5172-089
- Status last verified
- Nov 2017
- First submitted
- 4 May 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site, Open-Label, Trial of the Efficacy and Safety of Fixed-dose Elbasvir/Grazoprevir (EBR/GZR) in Brazilian Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 Infection With Advanced Fibrosis (F3 and F4)
- ClinicalTrials.gov ID
- NCT03143998
- Acronym / sponsor ID
- 5172-089
- Conditions
- Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2018 (estimated)
- Primary completion
- 12 Jan 2019 (estimated)
- Study completion
- 12 Jan 2019 (estimated)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-randomized, open-label study of a fixed dose combination (FDC) of elbasvir (50 mg) and grazoprevir (100 mg) (EBR/GZR or MK-5172A) in participants with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection with advanced fibrosis with and without human immunodeficiency virus (HIV) co-infection. All participants will be either HCV treatment naïve (TN) or treatment experienced (TE).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HCV GT1a TN | Experimental | Drug: MK-5172AParticipants with HCV GT1a infection who are TN will take MK-5172A for 12 weeks. |
| HCV GT1a TE | Experimental | Drug: MK-5172AParticipants with HCV GT1a infection who are TE will take MK-5172A for 12 weeks. |
| HCV GT1b TN | Experimental | Drug: MK-5172AParticipants with HCV GT1b infection who are TN will take MK-5172A for 12 weeks. |
| HCV GT1b TE | Experimental | Drug: MK-5172AParticipants with HCV GT1b infection who are TE will take MK-5172A for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adult (≥ 18 years of age) male and female participants with chronic HCV GT1 infection who reside in Brazil
- HCV RNA (≥ 10,000 IU/mL in peripheral blood) at the time of screening
- Has documented chronic HCV GT1 (1a; 1b) infection (with no evidence of non-typeable or mixed genotype) infection.
- Is otherwise healthy as determined by the medical history, physical examination, and clinical laboratory measurements at the time of screening
- Has a history of advanced fibrosis (F3 or F4) as follows:
Key exclusion criteria (9 listed)
- Has prior treatment with direct acting antiviral (DAA) therapy with the exception of boceprevir, telaprevir, and simeprevir
- Has evidence of decompensated liver disease as 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
- Is classified as Child-Pugh B or C or has a Child-Pugh-Turcotte score > 6
- Is hepatitis B surface antigen (HBsAg) positive at screening
- Is under evaluation for HCC or 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 |
|---|---|---|
| MK-5172AAlso: ZEPATIER®A single FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth. | Drug | HCV GT1a TE, HCV GT1a TN, HCV GT1b TE, HCV GT1b TN |
Primary outcome
Percentage of participants achieving sustained virologic response (SVR) 12 weeks after the end of all study therapy (SVR12)
Time frame: Week 24 (12 weeks after completing study therapy)
SVR12 will be declared when a participant has HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the end of all study therapy. Levels of HCV RNA will be determined with the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0, which has a LLoQ of 15 IU/mL.
Percentage of participants experiencing an adverse event (AE)
Time frame: Up to 14 weeks
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Percentage of participants withdrawing from study therapy due to an AE
Time frame: Up to 12 weeks
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
2 secondary outcomes
Percentage of participants achieving SVR 24 weeks after the end of all study therapy (SVR24)
Time frame: Week 36 (24 weeks after completing study therapy)
Emergence of viral resistance-associated variants (RAVs)
Time frame: Up to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MK-5172A in people with Hepatitis C, run by Merck Sharp & Dohme LLC.
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 14 inclusion and 9 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: withdrawn, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 (SVR) 12 weeks after the end of all study therapy (SVR12) (time frame: Week 24 (12 weeks after completing study therapy)). 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?
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 Nov 2017.