Hepatitis CPhase 2NCT02956629

Efficacy and Safety of Uprifosbuvir (MK-3682) + Ruzasvir (MK-8408) in Treating Hepatitis C Virus Infection Genotypes 1-6 (MK-3682-041)

A Phase 2 study testing Uprifosbuvir, Ruzasvir and Ribavirin in people with Hepatitis C, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C
What is being tested?: Uprifosbuvir, Ruzasvir and Ribavirin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 282 participants
Where: No sites listed yet
Study dates: 16 Nov 2016to 5 Mar 2018
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

has HCV ribonucleic acid (RNA) (≥10,000 IU/mL in peripheral blood) at the time of screening
has documented chronic HCV GT1, GT2, GT3, GT4, GT5, or GT6 (with no evidence of non-typeable or mixed GT)
is a female who is not of reproductive potential, or is a female of reproductive potential who agrees to avoid becoming pregnant from two weeks prior to Day 1 through 14 days after the last dose of study drug via abstinence or use of two approved contraceptives
is C or NC
if coinfected with HIV, has documented HIV infection prior to Day 1, and either does not use an antiretroviral therapy (ART) or has well-controlled HIV on stable ART (at least 4 weeks prior to study entry)

Who cannot join

has evidence of decompensated liver disease
is C and is Child-Pugh Class B or C, or has a Child-Tucotte-Pugh score >6
is coinfected with hepatitis B virus (hepatitis B surface antigen or hepatitis B core antibody positive)
is coinfected with HIV and has a recent (within 6 months prior to screening) opportunistic infection
has a history of malignancy other than adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ within 5 years of signing informed consent
is C and has evidence (liver imaging within 6 months prior to Day 1) of hepatocellular carcinoma (HCC) or is under evaluation for HCC

Show all 10Show fewer

has participated in another investigational drug study within 30 days of signing informed consent
is a female who is pregnant or breastfeeding or expecting to conceive or donate eggs from Day 1 through 6 months after the last dose of study drug or longer if dictated by local regulations, or is a male who is expecting to donate sperm from Day 1 through 14 days after the last dose of study drug or longer if dictated by local regulations, or is a male whose female partner(s) is/are pregnant or breastfeeding
has clinically relevant alcohol or drug abuse within 12 months of screening
has any of the following conditions: organ transplants other than cornea and hair; poor venous access; history of gastric surgery; clinically significant cardiac abnormality/dysfunction; any major medical condition which, in the opinion of the investigator, might interfere with participation; hospitalization within 3 months prior to enrollment; any condition that might require hospitalization; any condition requiring or likely to require chronic systemic administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or immunosuppressant drugs; a life-threatening SAE during screening; or hepatitis not caused by HCV

About this study

Official title: A Phase 2, Open-Label Clinical Trial to Study the Efficacy and Safety of 12 Weeks of the Combination Regimen of MK-3682 + Ruzasvir in Subjects With Chronic Hepatitis C Virus (HCV) Genotype 1, 2, 3, 4, 5 or 6 Infection

This is a nonrandomized, multi-site, open-label trial to evaluate a novel two-drug combination regimen (uprifosbuvir [MK-3682] 450 mg + ruzasvir [RZR; MK-8408] 180 mg once daily [q.d.] for 12 weeks) in male and female treatment-naïve (TN) or treatment-experienced (TE) participants with chronic hepatitis C virus (HCV) infection genotype (GT) GT1, GT2, GT3, GT4, GT5, or GT6 who have not previously received HCV direct-acting antiviral (DAA) therapy. Cirrhotic (C) and non-cirrhotic (NC) participants with and without human immunodeficiency virus (HIV) co-infection will be enrolled.

Read the detailed description

Any GT that meets virologic futility criteria will be given the option of extending treatment with uprifosbuvir + RZR to 16 weeks with ribavirin (RBV) added.

Conditions: Hepatitis C
Being tested: Uprifosbuvir, Ruzasvir, Ribavirin
Medical subject headings: Hepatitis C

What participants receive

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

UprifosbuvirDrug
Also called MK-3682
Participants take 3 tablets each containing 150 mg uprifosbuvir q.d. by mouth.
RuzasvirDrug
Also called MK-8408
Participants take 3 capsules each containing 60 mg RZR q.d. by mouth.
RibavirinDrug
RBV 200 mg capsules will be taken according to package instructions for a maximum of 16 weeks for any GT that meets virologic futility rules on uprifosbuvir + RZR alone.

Study groups in NCT02956629
Study group	Role	What they receive
HCV GT1	Experimental	Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Receives: Drug: Uprifosbuvir; Drug: Ruzasvir; Drug: Ribavirin
HCV GT2	Experimental	Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Receives: Drug: Uprifosbuvir; Drug: Ruzasvir; Drug: Ribavirin
HCV GT3	Experimental	Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Receives: Drug: Uprifosbuvir; Drug: Ruzasvir; Drug: Ribavirin
HCV GT4	Experimental	Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Receives: Drug: Uprifosbuvir; Drug: Ruzasvir; Drug: Ribavirin
HCV GT5	Experimental	Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Receives: Drug: Uprifosbuvir; Drug: Ruzasvir; Drug: Ribavirin
HCV GT6	Experimental	Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Receives: Drug: Uprifosbuvir; Drug: Ruzasvir; Drug: Ribavirin

What is being measured

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

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Completing Study Therapy (SVR12)
Plasma levels of hepatitis C virus (HCV) ribonucleic acid (RNA) were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from participants. SVR12 is the absence of detectable RNA of the hepatitis C virus, (<lower limit of quantification [LLOQ] of 15 IU/mL) for at least 12 weeks after completing treatment.
Measured: 12 weeks after completing study therapy (Week 24)
Percentage of Participants Experiencing an Adverse Event (AE)
An adverse event (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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Measured: Up to Week 14
Percentage of Participants Experiencing an AE of Clinical Importance (ECI)
Adverse events of clinical importance, excluding overdoses include, but is not limited to, significant changes in alanine aminotransferase, aspartate aminotransferase, blood creatinine, glomerular filtration rate or hepatitis B reactivation.
Measured: Up to Week 14
Percentage of Participants Experiencing a Serious Adverse Event (SAE)
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is an other important medical event; is a cancer; is associated with an overdose.
Measured: Up to Week 14
Percentage of Participants Experiencing a Drug-related 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE is determined by the investigator to be related to the use of the drug.
Measured: Up to Week 14
Percentage of Participants Experiencing a Drug-related SAE
A SAE is any AE occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is an other important medical event; is a cancer; is associated with an overdose. A drug-related SAE is determined by the investigator to be related to the use of the drug.
Measured: Up to Week 14
Percentage of Participants Discontinuing Study Therapy 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Measured: Up to Week 12

Secondary outcomes (2)

Percentage of Participants With SVR 24 Weeks After Completing Study Therapy (SVR24)
Plasma levels of HCV RNA) were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from participants. SVR24 is the absence of detectable RNA of the hepatitis C virus (<LLOQ of 15 IU/mL), for at least 24 weeks after completing treatment.
Measured: 24 weeks after completing study therapy (Week 36)
Percentage of Participants With Virologic Failure
Virologic failure is the detection of HCV RNA among participants who do not discontinue study for non-treatment-related reasons, either due to on-treatment failure defined as either non-response where HCV RNA is detected at end of treatment without HCV RNA <LLOQ having been achieved while on treatment; rebound defined as >1 log10 IU/mL increase in HCV RNA from nadir while on treatment and confirmed from a separate blood draw within 2 weeks; or virologic breakthrough which is confirmed HCV RNA ≥LLOQ (target detected, quantifiable [TD(q)]) after being <LLOQ previously while on treatment. Confirmation is defined as an HCV RNA ≥LLOQ from a separate blood draw repeated within 2 weeks; or relapse post-treatment. where there is a confirmed HCV RNA ≥LLOQ [TD(q)] following end of all study therapy, after becoming undetectable (target not detected [TND]) at end of treatment. Confirmation is defined as an HCV RNA ≥LLOQ from a separate blood draw repeated within 2 weeks.
Measured: Up to Week 24

Timeline

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

16 Nov 20165 Mar 2018

First posted7 Nov 2016 (estimated)
Study start16 Nov 2016
Primary completion22 Dec 2017
Study completion5 Mar 2018

Why it stopped: The study was terminated based on review of Phase 2 efficacy data

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 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 282 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02956629
Sponsor's protocol ID: 3682-041
Other IDs: 2016-003227-37, MK-3682-041, 2016
Status last verified: Jan 2021
First submitted: 2 Nov 2016
Last updated: 2 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Lawitz E, Gane E, Feld JJ, Buti M, Foster GR, Rabinovitz M, Burnevich E, Katchman H, Tomasiewicz K, Lahser F, Jackson B, Shaughnessy M, Klopfer S, Yeh WW, Robertson MN, Hanna GJ, Barr E, Platt HL; C-BREEZE-2 Study Investigators. Efficacy and safety of a two-drug direct-acting antiviral agent regimen ruzasvir 180 mg and uprifosbuvir 450 mg for 12 weeks in adults with chronic hepatitis C virus genotype 1, 2, 3, 4, 5 or 6. J Viral Hepat. 2019 Sep;26(9):1127-1138. doi: 10.1111/jvh.13132. Epub 2019 Jul 11.
PubMed 31108015

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?

Official record

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Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
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Diabetes Mellitus, Hepatitis C, Chronic

All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Open-Label Clinical Trial to Study the Efficacy and Safety of 12 Weeks of the Combination Regimen of MK-3682 + Ruzasvir in Subjects With Chronic Hepatitis C Virus (HCV) Genotype 1, 2, 3, 4, 5 or 6 Infection
ClinicalTrials.gov ID: NCT02956629
Acronym / sponsor ID: 3682-041
Conditions: Hepatitis C
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated based on review of Phase 2 efficacy data
Enrolment: 282 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 16 Nov 2016 (actual)
Primary completion: 22 Dec 2017 (actual)
Study completion: 5 Mar 2018 (actual)
First posted: 7 Nov 2016 (estimated)
Results: Posted 26 Dec 2018

Clinical summary

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

Detailed description

Any GT that meets virologic futility criteria will be given the option of extending treatment with uprifosbuvir + RZR to 16 weeks with ribavirin (RBV) added.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
HCV GT1	Experimental	Drug: Uprifosbuvir, Drug: Ruzasvir, Drug: RibavirinMale and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
HCV GT2	Experimental	Drug: Uprifosbuvir, Drug: Ruzasvir, Drug: RibavirinMale and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
HCV GT3	Experimental	Drug: Uprifosbuvir, Drug: Ruzasvir, Drug: RibavirinMale and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
HCV GT4	Experimental	Drug: Uprifosbuvir, Drug: Ruzasvir, Drug: RibavirinMale and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
HCV GT5	Experimental	Drug: Uprifosbuvir, Drug: Ruzasvir, Drug: RibavirinMale and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
HCV GT6	Experimental	Drug: Uprifosbuvir, Drug: Ruzasvir, Drug: RibavirinMale and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg 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 (5 listed)

has HCV ribonucleic acid (RNA) (≥10,000 IU/mL in peripheral blood) at the time of screening
has documented chronic HCV GT1, GT2, GT3, GT4, GT5, or GT6 (with no evidence of non-typeable or mixed GT)
is a female who is not of reproductive potential, or is a female of reproductive potential who agrees to avoid becoming pregnant from two weeks prior to Day 1 through 14 days after the last dose of study drug via abstinence or use of two approved contraceptives
is C or NC
if coinfected with HIV, has documented HIV infection prior to Day 1, and either does not use an antiretroviral therapy (ART) or has well-controlled HIV on stable ART (at least 4 weeks prior to study entry)

Key exclusion criteria (10 listed)

has evidence of decompensated liver disease
is C and is Child-Pugh Class B or C, or has a Child-Tucotte-Pugh score >6
is coinfected with hepatitis B virus (hepatitis B surface antigen or hepatitis B core antibody positive)
is coinfected with HIV and has a recent (within 6 months prior to screening) opportunistic infection
has a history of malignancy other than adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ within 5 years of signing informed consent

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
UprifosbuvirAlso: MK-3682Participants take 3 tablets each containing 150 mg uprifosbuvir q.d. by mouth.	Drug	HCV GT1, HCV GT2, HCV GT3, HCV GT4, HCV GT5, HCV GT6
RuzasvirAlso: MK-8408Participants take 3 capsules each containing 60 mg RZR q.d. by mouth.	Drug	HCV GT1, HCV GT2, HCV GT3, HCV GT4, HCV GT5, HCV GT6
RibavirinRBV 200 mg capsules will be taken according to package instructions for a maximum of 16 weeks for any GT that meets virologic futility rules on uprifosbuvir + RZR alone.	Drug	HCV GT1, HCV GT2, HCV GT3, HCV GT4, HCV GT5, HCV GT6

Primary outcome

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Completing Study Therapy (SVR12)
Time frame: 12 weeks after completing study therapy (Week 24)
Plasma levels of hepatitis C virus (HCV) ribonucleic acid (RNA) were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from participants. SVR12 is the absence of detectable RNA of the hepatitis C virus, (<lower limit of quantification [LLOQ] of 15 IU/mL) for at least 12 weeks after completing treatment.
Percentage of Participants Experiencing an Adverse Event (AE)
Time frame: Up to Week 14
An adverse event (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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Percentage of Participants Experiencing an AE of Clinical Importance (ECI)
Time frame: Up to Week 14
Adverse events of clinical importance, excluding overdoses include, but is not limited to, significant changes in alanine aminotransferase, aspartate aminotransferase, blood creatinine, glomerular filtration rate or hepatitis B reactivation.
Percentage of Participants Experiencing a Serious Adverse Event (SAE)
Time frame: Up to Week 14
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is an other important medical event; is a cancer; is associated with an overdose.
Percentage of Participants Experiencing a Drug-related AE
Time frame: Up to Week 14
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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE is determined by the investigator to be related to the use of the drug.
Percentage of Participants Experiencing a Drug-related SAE
Time frame: Up to Week 14
A SAE is any AE occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is an other important medical event; is a cancer; is associated with an overdose. A drug-related SAE is determined by the investigator to be related to the use of the drug.
Percentage of Participants Discontinuing Study Therapy Due to an AE
Time frame: Up to 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

2 secondary outcomes

Percentage of Participants With SVR 24 Weeks After Completing Study Therapy (SVR24)
Time frame: 24 weeks after completing study therapy (Week 36)
Percentage of Participants With Virologic Failure
Time frame: Up to Week 24

Results and safety

Results posted to the registry on 26 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HCV Genotype (GT) 1	78	73
HCV GT2	47	41
HCV GT3	61	57
HCV GT4	56	55
HCV GT5	18	18
HCV GT6	22	21

Primary outcome: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Completing Study Therapy (SVR12)

Time frame: 12 weeks after completing study therapy (Week 24). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	HCV GT1 n = 78	HCV GT2 n = 47	HCV GT3 n = 61	HCV GT4 n = 56	HCV GT5 n = 18	HCV GT6 n = 22
Value	92.3 (84.0 to 97.1)	91.5 (79.6 to 97.6)	73.8 (60.9 to 84.2)	98.2 (90.4 to 100.0)	100.0 (81.5 to 100.0)	90.9 (70.8 to 98.9)

Population analysed: All participants who were assigned to treatment, and received at least one dose of study medication.

Primary outcome: Percentage of Participants Experiencing an Adverse Event (AE)

Time frame: Up to Week 14. Number. Unit: Percentage of participants

Measure	HCV GT1 n = 78	HCV GT2 n = 47	HCV GT3 n = 61	HCV GT4 n = 56	HCV GT5 n = 18	HCV GT6 n = 22
Value	60.3	61.7	57.4	55.4	77.8	77.3

Population analysed: All participants who received at least one dose of study treatment.

Primary outcome: Percentage of Participants Experiencing an AE of Clinical Importance (ECI)

Time frame: Up to Week 14. Number. Unit: Percentage of participants

Measure	HCV GT1 n = 78	HCV GT2 n = 47	HCV GT3 n = 61	HCV GT4 n = 56	HCV GT5 n = 18	HCV GT6 n = 22
Value	1.3	2.1	1.6	3.6	0	0

Population analysed: All participants who received at least one dose of study treatment

Primary outcome: Percentage of Participants Experiencing a Serious Adverse Event (SAE)

Time frame: Up to Week 14. Number. Unit: Percentage of participants

Measure	HCV GT1 n = 78	HCV GT2 n = 47	HCV GT3 n = 61	HCV GT4 n = 56	HCV GT5 n = 18	HCV GT6 n = 22
Value	3.8	2.1	1.6	3.6	0	0

Population analysed: All participants who received at least one dose of study treatment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 14. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HCV GT1	3 of 78 (3.8%)	28 of 78 (35.9%)	0 of 78
HCV GT2	1 of 47 (2.1%)	20 of 47 (42.6%)	0 of 47
HCV GT3	1 of 61 (1.6%)	30 of 61 (49.2%)	0 of 61
HCV GT4	2 of 56 (3.6%)	22 of 56 (39.3%)	0 of 56
HCV GT5	0 of 18 (0%)	14 of 18 (77.8%)	0 of 18
HCV GT6	0 of 22 (0%)	10 of 22 (45.5%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31108015Lawitz E, Gane E, Feld JJ, Buti M, Foster GR, Rabinovitz M, Burnevich E, Katchman H, Tomasiewicz K, Lahser F, Jackson B, Shaughnessy M, Klopfer S, Yeh WW, Robertson MN, Hanna GJ, Barr E, Platt HL; C-BREEZE-2 Study Investigators. Efficacy and safety of a two-drug direct-acting antiviral agent regimen ruzasvir 180 mg and uprifosbuvir 450 mg for 12 weeks in adults with chronic hepatitis C virus genotype 1, 2, 3, 4, 5 or 6. J Viral Hepat. 2019 Sep;26(9):1127-1138. doi: 10.1111/jvh.13132. Epub 2019 Jul 11.
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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Uprifosbuvir, Ruzasvir and Ribavirin 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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 2 Feb 2021. 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 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 26 Dec 2018). 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 With Sustained Virologic Response (SVR) 12 Weeks After Completing Study Therapy (SVR12) (time frame: 12 weeks after completing study therapy (Week 24)). The study lists 7 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 NCT02956629, 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 2 Feb 2021.