Hepatitis CPhase 2NCT02332707

Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Genotype (GT)1 and GT2 Infection (MK-3682-011)

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

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
What is being tested?: Grazoprevir, Uprifosbuvir and Elbasvir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 443 participants
Where: No sites listed yet
Study dates: 22 Jan 2015to 6 Dec 2016
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

Parts A and B:
Previously untreated chronic HCV GT1 or GT2 with no evidence of non-typeable or mixed genotype infection
Has HCV ribonucleic acid (RNA) >= 10,000 IU/mL in peripheral blood at the time of screening
Is NC (Part A and B)
Is HCV treatment naïve (defined as no prior exposure to any interferon, ribavirin, or other approved or experimental HCV-specific direct-acting antiviral agent
Is of non-childbearing potential or agrees to avoid becoming pregnant or impregnating a partner beginning at least 2 weeks prior to administration of the initial dose of study drug and either for 14 days after the last dose of study drug if not taking RBV or for 6 months after the last dose of study drug if taking RBV (or longer if dictated by local regulations). If not abstinent from heterosexual activity, participants in Part A must use 2 acceptable forms of barrier contraception whereas participants in Part B must use 2 acceptable forms of contraception which may include oral contraceptives

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Part B only:
Has cirrhosis of the liver
If coinfected with human immunodeficiency virus (HIV) is not currently on antiretroviral therapy (ART) and has no plans to initiate ART treatment while participating in this study OR has well controlled HIV on ART (the ART regimen must contain only the following antiretroviral medications: tenofovir, abacavir, lamivudine, emtricitabine, raltegravir, dolutegravir, and rilpivirine with no dose modifications or changes in drugs in the 4 weeks prior to study entry [Day 1])
Has at least one viable ART regimen alternative beyond their current regimen in the event of HIV virologic failure and the development of antiretroviral drug resistance

Who cannot join

Parts A, B, and C (unless noted otherwise):
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
For cirrhotics (Part B only), participants who are Child-Pugh Class B or C or who have a Pugh-Turcotte (CPT) score >5
Is coinfected with hepatitis B virus
Is coinfected with HIV (Part A only)
If coinfected with HIV (Part B only), has a history of opportunistic infection in the preceding 6 months prior to screening

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Has a history of malignancy <=5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy
Has cirrhosis and has had liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
Has clinically-relevant drug or alcohol abuse within 12 months of screening
Pregnant or breast-feeding, or expecting to conceive or donate eggs from at least 2 weeks prior to Day 1 and 90 days after the last dose of study medication, or longer if dictated by local regulations
Has any of the following conditions:
organ transplants (including hematopoietic stem cell transplants) other than cornea and hair
poor venous access that precludes routine peripheral blood sampling required for this trial
has a history of gastric surgery (e.g., stapling, bypass) or history of malabsorption disorders (e.g., celiac sprue disease)
current or history of any clinically significant cardiac abnormalities/dysfunction, including but not limited to: angina, congestive heart failure, myocardial infarction, pulmonary hypertension, complex congenital heart disease, cardiomyopathy, significant arrhythmia, uncontrolled hypertension, a history of use of antianginal or anti-arrhythmic agents for cardiac conditions, prolonged electrocardiogram (ECG) QTc interval (>470 ms for males or >480 ms for females by the Fridericia formula) at the screening visit, personal or family history of Torsade de pointes
chronic pulmonary disease, including but not limited to: clinically significant chronic obstructive pulmonary disease, interstitial lung disease, pulmonary fibrosis, sarcoidosis
central nervous system (CNS) trauma requiring intubation, intracranial pressure monitoring, brain meningeal or skull surgery, or resulting in seizure, coma, permanent neurologic deficits, abnormal brain imaging, or cerebral spinal fluid (CSF) leak. Prior brain hemorrhage and/or intracranial aneurysms (whether adequately repaired or not)
a current, or history of, seizure disorder unless seizure was >10 years ago, a single isolated event, no history of or current use of anti-seizure medications prescribed, and a normal neurological examination is documented in trial files within 6 months of Day 1
a history of stroke or transient ischemic attack
a history of a medical/surgical condition that resulted in hospitalization within the 3 months prior to enrollment, other than for minor elective procedures
a medical/surgical conditions that may result in a need for hospitalization during the period of the study
any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other immunosuppressant drugs during the course of the trial
has any condition, prestudy laboratory or ECG abnormality or history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the subject
experiences a life-threatening serious adverse event (SAE) during the screening period
evidence of history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, hemochromatosis, Wilson's disease, α1-antitrypsin deficiency, alcoholic liver disease, and autoimmune hepatitis
hemoglobinopathy, including, but not limited to, thalassemia major (Parts B and C only) Parts B and C only: is a male whose female partner(s) is/are pregnant

About this study

Official title: A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 With Either MK-8742 or MK-8408 in Subjects With Chronic HCV GT1 and GT2 Infection

This is a randomized, three-part, open-label trial of grazoprevir (GZR; MK-5172) (100 mg) and uprifosbuvir (UPR; MK-3682) (300 mg or 450 mg), with either elbasvir (EBR; MK-8742) (50 mg) or ruzasvir (RZR; MK-8408) (60 mg), and with or without ribavirin (RBV), in treatment-naïve (TN) cirrhotic (C) or non-cirrhotic (NC) hepatitis C virus (HCV) participants with chronic HCV genotype (GT) 1 or GT2 infection. Part A will consist of 8 arms to evaluate the safety of dose combinations. In Part B, participants will take 2 UPR+GZR+RZR fixed dose combination (FDC) tablets once daily (q.d.) by mouth, with or without twice-daily (b.i.d.) RBV (200 mg capsules; weight-based dosing). Participants who relapse following completion of therapy in Part A will be offered the option of retreatment with 16 weeks of UPR+GZR+RZR with RBV in Part C (data obtained from Part C will not be used in the analysis of outcome measures).

Read the detailed description

In Part A, study therapy will be administered as separate products, each taken q.d. by mouth. In Part B and Part C, participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg q.d. by mouth.

Conditions: Hepatitis C
Being tested: Grazoprevir, Uprifosbuvir, Elbasvir, Ruzasvir, Uprifosbuvir (+) Grazoprevir (+) Ruzasvir
Medical subject headings: Hepatitis C

What participants receive

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

GrazoprevirDrug
Also called MK-5172
One GZR 100 mg tablet (Part A), or 2 FDC tablets containing GZR 50 mg per tablet (Part B), taken q.d.by mouth.
UprifosbuvirDrug
Also called MK-3682
Two or 3 UPR 150 mg (300 mg and 450 mg total daily dose) tablets (Part A), or 2 FDC tablets containing UPR 225 mg (Part B), taken q.d. by mouth.
ElbasvirDrug
Also called MK-8742
One EBR 50 mg tablet (Part A), taken q.d. by mouth.
RuzasvirDrug
Also called MK-8408
Six RZR 10 mg (60 mg total daily dose) capsules (Part A), or 2 FDC tablets containing RZR 30 mg per tablet (Part B), taken q.d. by mouth.
Uprifosbuvir (+) Grazoprevir (+) RuzasvirDrug
Also called MK-3682B
Two FDC tablets, each containing GZR 50 mg + UPR 225 mg + RZR 30 mg (Part B), taken q.d. by mouth.
RibavirinDrug
Also called Rebetol®
RBV 200 mg capsules taken b.i.d. at a total daily dose of 800-1400 mg based on participant body weight.

Study groups in NCT02332707
Study group	Role	What they receive
A1: GT1 NC GZR+UPR+EBR (8 weeks)	Experimental	In Part A, HCV GT1-infected NC participants will take GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks. Receives: Drug: Grazoprevir; Drug: Uprifosbuvir; Drug: Elbasvir
A2: GT1 NC GZR+UPR+RZR (8 weeks)	Experimental	In Part A, HCV GT1-infected NC participants will take GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks. Receives: Drug: Grazoprevir; Drug: Uprifosbuvir; Drug: Ruzasvir
A3: GT2 NC GZR+UPR+EBR (8 weeks)	Experimental	In Part A, HCV GT2-infected NC participants will take GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks. Receives: Drug: Grazoprevir; Drug: Uprifosbuvir; Drug: Elbasvir
A4: GT2 NC GZR+UPR+RZR (8 weeks)	Experimental	In Part A, HCV GT2-infected NC participants will take GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks. Receives: Drug: Grazoprevir; Drug: Uprifosbuvir; Drug: Ruzasvir
A5: GT1 NC GZR+UPR+EBR (8 weeks)	Experimental	In Part A, HCV GT1-infected NC participants will take GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks. Receives: Drug: Grazoprevir; Drug: Uprifosbuvir; Drug: Elbasvir
A6: GT1 NC GZR+UPR+RZR (8 weeks)	Experimental	In Part A, HCV GT1-infected NC participants will take GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks. Receives: Drug: Grazoprevir; Drug: Uprifosbuvir; Drug: Ruzasvir
B7: GT2 NC GZR+UPR+EBR (8 weeks)	Experimental	In Part A, HCV GT2-infected NC participants will take GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks. Receives: Drug: Grazoprevir; Drug: Uprifosbuvir; Drug: Elbasvir
A8: GT2 NC GZR+UPR+RZR (8 weeks)	Experimental	In Part A, HCV GT2-infected NC participants will take GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks. In Part B, HCV GT2-infected NC participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Receives: Drug: Grazoprevir; Drug: Uprifosbuvir; Drug: Ruzasvir
B9: GT1 NC GZR+UPR+RZR (12 weeks)	Experimental	In Part B, HCV GT1-infected NC participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Receives: Drug: Grazoprevir; Drug: Uprifosbuvir; Drug: Ruzasvir; Drug: Uprifosbuvir (+) Grazoprevir (+) Ruzasvir
B10: GT2 NC GZR+UPR+RZR (8 weeks) + RBV	Experimental	In Part B, HCV GT2-infected NC participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight. Receives: Drug: Grazoprevir; Drug: Uprifosbuvir; Drug: Ruzasvir; Drug: Uprifosbuvir (+) Grazoprevir (+) Ruzasvir; Drug: Ribavirin
B11: GT2 NC GZR+UPR+RZR (12 weeks)	Experimental	In Part B, HCV GT2-infected NC participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Receives: Drug: Grazoprevir; Drug: Uprifosbuvir; Drug: Ruzasvir; Drug: Uprifosbuvir (+) Grazoprevir (+) Ruzasvir
B12: GT1 C GZR+UPR+RZR (8 weeks)	Experimental	In Part B, HCV GT1-infected C participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Receives: Drug: Grazoprevir; Drug: Uprifosbuvir; Drug: Ruzasvir; Drug: Uprifosbuvir (+) Grazoprevir (+) Ruzasvir
B13: GT1 C GZR+UPR+RZR (12 weeks)	Experimental	In Part B, HCV GT1-infected C participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Receives: Drug: Grazoprevir; Drug: Uprifosbuvir; Drug: Ruzasvir; Drug: Uprifosbuvir (+) Grazoprevir (+) Ruzasvir
B14: GT2 C GZR+UPR+RZR (12 weeks)	Experimental	In Part B, HCV GT2-infected C participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Receives: Drug: Grazoprevir; Drug: Uprifosbuvir; Drug: Ruzasvir; Drug: Uprifosbuvir (+) Grazoprevir (+) Ruzasvir
B15: GT2 C GZR+UPR+RZR (12 weeks) + RBV	Experimental	In Part B, HCV GT2-infected C participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight. Receives: Drug: Grazoprevir; Drug: Uprifosbuvir; Drug: Ruzasvir; Drug: Uprifosbuvir (+) Grazoprevir (+) Ruzasvir; Drug: Ribavirin
B16: GT2 C GZR+UPR+RZR (16 weeks)	Experimental	In Part B, HCV GT2-infected C participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks. Receives: Drug: Grazoprevir; Drug: Uprifosbuvir; Drug: Ruzasvir; Drug: Uprifosbuvir (+) Grazoprevir (+) Ruzasvir
B6: GT1 NC GZR+UPR+RZR (8 weeks)	Experimental	In Part B, HCV GT1-infected NC participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Receives: Drug: Uprifosbuvir (+) Grazoprevir (+) Ruzasvir
B8: GT2 NC GZR+UPR+RZR (8 weeks)	Experimental	In Part B, HCV GT2-infected NC participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Receives: Drug: Uprifosbuvir (+) Grazoprevir (+) Ruzasvir

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 Completing Treatment (SVR12)
The percentage of participants with Hepatitis C virus (HCV) ribonucleic acid (RNA) < Lower Limit of Quantification (LLoQ) 12 weeks after completing treatment (i.e., SVR12) in each arm was determined. Plasma levels of HCV RNA levels were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 assay, which has a LLoQ of 15 IU/mL.
Measured: Up to 28 weeks
Percentage of Participants Experiencing an Adverse Event (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 18 weeks
Percentage of Participants Discontinuing 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 16 weeks

Secondary outcomes (1)

Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Ending Study Treatment (SVR24)
The percentage of participants with HCV RNA < LLoQ 24 weeks after completing treatment (i.e., SVR24) in each arm was determined. Plasma levels of HCV RNA levels were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 assay, which has a LLoQ of 15 IU/mL.
Measured: Up to 40 weeks

Timeline

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

22 Jan 20156 Dec 2016

First posted7 Jan 2015 (estimated)
Study start22 Jan 2015
Primary completion16 Sep 2016
Study completion6 Dec 2016

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 (2)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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 443 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02332707
Sponsor's protocol ID: 3682-011
Other IDs: 2014-003304-73, MK-3682-011, 2014
Status last verified: Jul 2019
First submitted: 6 Jan 2015
Last updated: 23 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Lawitz E, Buti M, Vierling JM, Almasio PL, Bruno S, Ruane PJ, Hassanein TI, Muellhaupt B, Pearlman B, Jancoriene L, Gao W, Huang HC, Shepherd A, Tannenbaum B, Fernsler D, Li JJ, Grandhi A, Liu H, Su FH, Wan S, Dutko FJ, Nguyen BT, Wahl J, Robertson MN, Barr E, Yeh WW, Plank RM, Butterton JR, Yoshida EM. Safety and efficacy of a fixed-dose combination regimen of grazoprevir, ruzasvir, and uprifosbuvir with or without ribavirin in participants with and without cirrhosis with chronic hepatitis C virus genotype 1, 2, or 3 infection (C-CREST-1 and C-CREST-2, part B): two randomised, phase 2, open-label trials. Lancet Gastroenterol Hepatol. 2017 Nov;2(11):814-823. doi: 10.1016/S2468-1253(17)30163-2. Epub 2017 Aug 10.
PubMed 28802814
Gane EJ, Pianko S, Roberts SK, Thompson AJ, Zeuzem S, Zuckerman E, Ben-Ari Z, Foster GR, Agarwal K, Laursen AL, Gerstoft J, Gao W, Huang HC, Fitzgerald B, Fernsler D, Li JJ, Grandhi A, Liu H, Su FH, Wan S, Zeng Z, Chen HL, Dutko FJ, Nguyen BT, Wahl J, Robertson MN, Barr E, Yeh WW, Plank RM, Butterton JR, Esteban R. Safety and efficacy of an 8-week regimen of grazoprevir plus ruzasvir plus uprifosbuvir compared with grazoprevir plus elbasvir plus uprifosbuvir in participants without cirrhosis infected with hepatitis C virus genotypes 1, 2, or 3 (C-CREST-1 and C-CREST-2, part A): two randomised, phase 2, open-label trials. Lancet Gastroenterol Hepatol. 2017 Nov;2(11):805-813. doi: 10.1016/S2468-1253(17)30159-0. Epub 2017 Aug 10.
PubMed 28802816

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

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
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
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 With Either MK-8742 or MK-8408 in Subjects With Chronic HCV GT1 and GT2 Infection
ClinicalTrials.gov ID: NCT02332707
Acronym / sponsor ID: 3682-011
Conditions: Hepatitis C
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 443 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 22 Jan 2015 (actual)
Primary completion: 16 Sep 2016 (actual)
Study completion: 6 Dec 2016 (actual)
First posted: 7 Jan 2015 (estimated)
Results: Posted 21 Dec 2017

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 18

Arm	Type	Receives
A1: GT1 NC GZR+UPR+EBR (8 weeks)	Experimental	Drug: Grazoprevir, Drug: Uprifosbuvir, Drug: ElbasvirIn Part A, HCV GT1-infected NC participants will take GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.
A2: GT1 NC GZR+UPR+RZR (8 weeks)	Experimental	Drug: Grazoprevir, Drug: Uprifosbuvir, Drug: RuzasvirIn Part A, HCV GT1-infected NC participants will take GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.
A3: GT2 NC GZR+UPR+EBR (8 weeks)	Experimental	Drug: Grazoprevir, Drug: Uprifosbuvir, Drug: ElbasvirIn Part A, HCV GT2-infected NC participants will take GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.
A4: GT2 NC GZR+UPR+RZR (8 weeks)	Experimental	Drug: Grazoprevir, Drug: Uprifosbuvir, Drug: RuzasvirIn Part A, HCV GT2-infected NC participants will take GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.
A5: GT1 NC GZR+UPR+EBR (8 weeks)	Experimental	Drug: Grazoprevir, Drug: Uprifosbuvir, Drug: ElbasvirIn Part A, HCV GT1-infected NC participants will take GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
A6: GT1 NC GZR+UPR+RZR (8 weeks)	Experimental	Drug: Grazoprevir, Drug: Uprifosbuvir, Drug: RuzasvirIn Part A, HCV GT1-infected NC participants will take GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.
B7: GT2 NC GZR+UPR+EBR (8 weeks)	Experimental	Drug: Grazoprevir, Drug: Uprifosbuvir, Drug: ElbasvirIn Part A, HCV GT2-infected NC participants will take GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.
A8: GT2 NC GZR+UPR+RZR (8 weeks)	Experimental	Drug: Grazoprevir, Drug: Uprifosbuvir, Drug: RuzasvirIn Part A, HCV GT2-infected NC participants will take GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks. In Part B, HCV GT2-infected NC participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
B9: GT1 NC GZR+UPR+RZR (12 weeks)	Experimental	Drug: Grazoprevir, Drug: Uprifosbuvir, Drug: Ruzasvir, Drug: Uprifosbuvir (+) Grazoprevir (+) RuzasvirIn Part B, HCV GT1-infected NC participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
B10: GT2 NC GZR+UPR+RZR (8 weeks) + RBV	Experimental	Drug: Grazoprevir, Drug: Uprifosbuvir, Drug: Ruzasvir, Drug: Uprifosbuvir (+) Grazoprevir (+) Ruzasvir, Drug: RibavirinIn Part B, HCV GT2-infected NC participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
B11: GT2 NC GZR+UPR+RZR (12 weeks)	Experimental	Drug: Grazoprevir, Drug: Uprifosbuvir, Drug: Ruzasvir, Drug: Uprifosbuvir (+) Grazoprevir (+) RuzasvirIn Part B, HCV GT2-infected NC participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
B12: GT1 C GZR+UPR+RZR (8 weeks)	Experimental	Drug: Grazoprevir, Drug: Uprifosbuvir, Drug: Ruzasvir, Drug: Uprifosbuvir (+) Grazoprevir (+) RuzasvirIn Part B, HCV GT1-infected C participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
B13: GT1 C GZR+UPR+RZR (12 weeks)	Experimental	Drug: Grazoprevir, Drug: Uprifosbuvir, Drug: Ruzasvir, Drug: Uprifosbuvir (+) Grazoprevir (+) RuzasvirIn Part B, HCV GT1-infected C participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
B14: GT2 C GZR+UPR+RZR (12 weeks)	Experimental	Drug: Grazoprevir, Drug: Uprifosbuvir, Drug: Ruzasvir, Drug: Uprifosbuvir (+) Grazoprevir (+) RuzasvirIn Part B, HCV GT2-infected C participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
B15: GT2 C GZR+UPR+RZR (12 weeks) + RBV	Experimental	Drug: Grazoprevir, Drug: Uprifosbuvir, Drug: Ruzasvir, Drug: Uprifosbuvir (+) Grazoprevir (+) Ruzasvir, Drug: RibavirinIn Part B, HCV GT2-infected C participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.
B16: GT2 C GZR+UPR+RZR (16 weeks)	Experimental	Drug: Grazoprevir, Drug: Uprifosbuvir, Drug: Ruzasvir, Drug: Uprifosbuvir (+) Grazoprevir (+) RuzasvirIn Part B, HCV GT2-infected C participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.
B6: GT1 NC GZR+UPR+RZR (8 weeks)	Experimental	Drug: Uprifosbuvir (+) Grazoprevir (+) RuzasvirIn Part B, HCV GT1-infected NC participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
B8: GT2 NC GZR+UPR+RZR (8 weeks)	Experimental	Drug: Uprifosbuvir (+) Grazoprevir (+) RuzasvirIn Part B, HCV GT2-infected NC participants will take 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.

Who may qualify

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

Key inclusion criteria (10 listed)

Previously untreated chronic HCV GT1 or GT2 with no evidence of non-typeable or mixed genotype infection
Has HCV ribonucleic acid (RNA) >= 10,000 IU/mL in peripheral blood at the time of screening
Is NC (Part A and B)
Is HCV treatment naïve (defined as no prior exposure to any interferon, ribavirin, or other approved or experimental HCV-specific direct-acting antiviral agent
Is of non-childbearing potential or agrees to avoid becoming pregnant or impregnating a partner beginning at least 2 weeks prior to administration of the initial dose of study drug and either for 14 days after the last dose of study drug if not taking RBV or for 6 months after the last dose of study drug if taking RBV (or longer if dictated by local regulations). If not abstinent from heterosexual activity, participants in Part A must use 2 acceptable forms of barrier contraception whereas participants in Part B must use 2 acceptable forms of contraception which may include oral contraceptives

Key exclusion criteria (26 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
For cirrhotics (Part B only), participants who are Child-Pugh Class B or C or who have a Pugh-Turcotte (CPT) score >5
Is coinfected with hepatitis B virus
Is coinfected with HIV (Part A only)
If coinfected with HIV (Part B only), has a history of opportunistic infection in the preceding 6 months prior to screening

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
GrazoprevirAlso: MK-5172One GZR 100 mg tablet (Part A), or 2 FDC tablets containing GZR 50 mg per tablet (Part B), taken q.d.by mouth.	Drug	A1: GT1 NC GZR+UPR+EBR (8 weeks), A2: GT1 NC GZR+UPR+RZR (8 weeks), A3: GT2 NC GZR+UPR+EBR (8 weeks), A4: GT2 NC GZR+UPR+RZR (8 weeks), A5: GT1 NC GZR+UPR+EBR (8 weeks), A6: GT1 NC GZR+UPR+RZR (8 weeks), A8: GT2 NC GZR+UPR+RZR (8 weeks), B10: GT2 NC GZR+UPR+RZR (8 weeks) + RBV, B11: GT2 NC GZR+UPR+RZR (12 weeks), B12: GT1 C GZR+UPR+RZR (8 weeks), B13: GT1 C GZR+UPR+RZR (12 weeks), B14: GT2 C GZR+UPR+RZR (12 weeks), B15: GT2 C GZR+UPR+RZR (12 weeks) + RBV, B16: GT2 C GZR+UPR+RZR (16 weeks), B7: GT2 NC GZR+UPR+EBR (8 weeks), B9: GT1 NC GZR+UPR+RZR (12 weeks)
UprifosbuvirAlso: MK-3682Two or 3 UPR 150 mg (300 mg and 450 mg total daily dose) tablets (Part A), or 2 FDC tablets containing UPR 225 mg (Part B), taken q.d. by mouth.	Drug	A1: GT1 NC GZR+UPR+EBR (8 weeks), A2: GT1 NC GZR+UPR+RZR (8 weeks), A3: GT2 NC GZR+UPR+EBR (8 weeks), A4: GT2 NC GZR+UPR+RZR (8 weeks), A5: GT1 NC GZR+UPR+EBR (8 weeks), A6: GT1 NC GZR+UPR+RZR (8 weeks), A8: GT2 NC GZR+UPR+RZR (8 weeks), B10: GT2 NC GZR+UPR+RZR (8 weeks) + RBV, B11: GT2 NC GZR+UPR+RZR (12 weeks), B12: GT1 C GZR+UPR+RZR (8 weeks), B13: GT1 C GZR+UPR+RZR (12 weeks), B14: GT2 C GZR+UPR+RZR (12 weeks), B15: GT2 C GZR+UPR+RZR (12 weeks) + RBV, B16: GT2 C GZR+UPR+RZR (16 weeks), B7: GT2 NC GZR+UPR+EBR (8 weeks), B9: GT1 NC GZR+UPR+RZR (12 weeks)
ElbasvirAlso: MK-8742One EBR 50 mg tablet (Part A), taken q.d. by mouth.	Drug	A1: GT1 NC GZR+UPR+EBR (8 weeks), A3: GT2 NC GZR+UPR+EBR (8 weeks), A5: GT1 NC GZR+UPR+EBR (8 weeks), B7: GT2 NC GZR+UPR+EBR (8 weeks)
RuzasvirAlso: MK-8408Six RZR 10 mg (60 mg total daily dose) capsules (Part A), or 2 FDC tablets containing RZR 30 mg per tablet (Part B), taken q.d. by mouth.	Drug	A2: GT1 NC GZR+UPR+RZR (8 weeks), A4: GT2 NC GZR+UPR+RZR (8 weeks), A6: GT1 NC GZR+UPR+RZR (8 weeks), A8: GT2 NC GZR+UPR+RZR (8 weeks), B10: GT2 NC GZR+UPR+RZR (8 weeks) + RBV, B11: GT2 NC GZR+UPR+RZR (12 weeks), B12: GT1 C GZR+UPR+RZR (8 weeks), B13: GT1 C GZR+UPR+RZR (12 weeks), B14: GT2 C GZR+UPR+RZR (12 weeks), B15: GT2 C GZR+UPR+RZR (12 weeks) + RBV, B16: GT2 C GZR+UPR+RZR (16 weeks), B9: GT1 NC GZR+UPR+RZR (12 weeks)
Uprifosbuvir (+) Grazoprevir (+) RuzasvirAlso: MK-3682BTwo FDC tablets, each containing GZR 50 mg + UPR 225 mg + RZR 30 mg (Part B), taken q.d. by mouth.	Drug	B10: GT2 NC GZR+UPR+RZR (8 weeks) + RBV, B11: GT2 NC GZR+UPR+RZR (12 weeks), B12: GT1 C GZR+UPR+RZR (8 weeks), B13: GT1 C GZR+UPR+RZR (12 weeks), B14: GT2 C GZR+UPR+RZR (12 weeks), B15: GT2 C GZR+UPR+RZR (12 weeks) + RBV, B16: GT2 C GZR+UPR+RZR (16 weeks), B6: GT1 NC GZR+UPR+RZR (8 weeks), B8: GT2 NC GZR+UPR+RZR (8 weeks), B9: GT1 NC GZR+UPR+RZR (12 weeks)
RibavirinAlso: Rebetol®RBV 200 mg capsules taken b.i.d. at a total daily dose of 800-1400 mg based on participant body weight.	Drug	B10: GT2 NC GZR+UPR+RZR (8 weeks) + RBV, B15: GT2 C GZR+UPR+RZR (12 weeks) + RBV

Primary outcome

Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Treatment (SVR12)
Time frame: Up to 28 weeks
The percentage of participants with Hepatitis C virus (HCV) ribonucleic acid (RNA) < Lower Limit of Quantification (LLoQ) 12 weeks after completing treatment (i.e., SVR12) in each arm was determined. Plasma levels of HCV RNA levels were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 assay, which has a LLoQ of 15 IU/mL.
Percentage of Participants Experiencing an Adverse Event (AE)
Time frame: Up to 18 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.
Percentage of Participants Discontinuing From Study Treatment Due to an AE
Time frame: Up to 16 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.

1 secondary outcome

Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Ending Study Treatment (SVR24)
Time frame: Up to 40 weeks

Results and safety

Results posted to the registry on 21 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A1: GT1 NC GZR+UPR+EBR (8 Weeks)	23	23
A2: GT1 NC GZR+UPR+RZR (8 Weeks)	24	24
A3: GT2 NC GZR+UPR+EBR (8 Weeks)	16	15
A4: GT2 NC GZR+UPR+RZR (8 Weeks)	14	13
A5: GT1 NC GZR+UPR+EBR (8 Weeks)	23	23
A6: GT1 NC GZR+UPR+RZR (8 Weeks)	23	22
A7: GT2 NC GZR+UPR+EBR (8 Weeks)	15	15
A8: GT2 NC GZR+UPR+RZR (8 Weeks)	16	16
B9: GT1 NC GZR+UPR+RZR (12 Weeks)	48	48
B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV	31	28
B11: GT2 NC GZR+UPR+RZR (12 Weeks)	31	29
B12: GT1 C GZR+UPR+RZR (8 Weeks)	35	35
B13: GT1 C GZR+UPR+RZR (12 Weeks)	40	35
B14: GT2 C GZR+UPR+RZR (12 Weeks)	15	15
B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV	16	16
B16: GT2 C GZR+UPR+RZR (16 Weeks)	26	26
B6: GT1 NC GZR+UPR+RZR (8 Weeks)	30	30
B8: GT2 NC GZR+UPR+RZR (8 Weeks)	16	16

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

Time frame: Up to 28 weeks. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	A1: GT1 NC GZR+UPR+EBR (8 Weeks) n = 23	A2: GT1 NC GZR+UPR+RZR (8 Weeks) n = 24	A3: GT2 NC GZR+UPR+EBR (8 Weeks) n = 16	A4: GT2 NC GZR+UPR+RZR (8 Weeks) n = 14	A5: GT1 NC GZR+UPR+EBR (8 Weeks) n = 23	A6: GT1 NC GZR+UPR+RZR (8 Weeks) n = 23	B6: GT1 NC GZR+UPR+RVR (8 Weeks) n = 30	A7: GT2 NC GZR+UPR+EBR (8 Weeks) n = 15	A8: GT2 NC GZR+UPR+RZR (8 Weeks) n = 16	B8: GT2 NC GZR+UPR+RZR (8 Weeks) n = 16	B9: GT1 NC GZR+UPR+RZR (12 Weeks) n = 48	B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV n = 30	B11: GT2 NC GZR+UPR+RZR (12 Weeks) n = 30	B12: GT1 C GZR+UPR+RZR (8 Weeks) n = 35	B13: GT1 C GZR+UPR+RZR (12 Weeks) n = 39	B14: GT2 C GZR+UPR+RZR (12 Weeks) n = 15	B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV n = 16	16: GT2 C GZR+UPR+RZR (16 Weeks) n = 25
Value	100.0 (85.2 to 100.0)	100.0 (85.8 to 100.0)	68.8 (41.3 to 89.0)	71.4 (41.9 to 91.6)	100.0 (85.2 to 100.0)	91.3 (72.0 to 98.9)	100.0 (88.4 to 100.0)	60.0 (32.3 to 83.7)	93.8 (69.8 to 99.8)	87.5 (61.7 to 98.4)	100.0 (92.6 to 100.0)	83.3 (65.3 to 94.4)	100.0 (88.4 to 100.0)	97.1 (85.1 to 99.9)	100.0 (91.0 to 100.0)	100.0 (78.2 to 100.0)	100.0 (79.4 to 100.0)	100.0 (86.3 to 100.0)

Population analysed: All randomized participants who received at least 1 dose of study drug and had SVR12 results available are included.

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

Time frame: Up to 18 weeks. Number. Unit: Percentage of Participants

Measure	A1: GT1 NC GZR+UPR+EBR (8 Weeks) n = 23	A2: GT1 NC GZR+UPR+RZR (8 Weeks) n = 24	A3: GT2 NC GZR+UPR+EBR (8 Weeks) n = 16	A4: GT2 NC GZR+UPR+RZR (8 Weeks) n = 14	A5: GT1 NC GZR+UPR+EBR (8 Weeks) n = 23	A6: GT1 NC GZR+UPR+RZR (8 Weeks) n = 23	B6: GT1 NC GZR+UPR+RVR (8 Weeks) n = 30	A7: GT2 NC GZR+UPR+EBR (8 Weeks) n = 15	A8: GT2 NC GZR+UPR+RZR (8 Weeks) n = 16	B8: GT2 NC GZR+UPR+RZR (8 Weeks) n = 16	B9: GT1 NC GZR+UPR+RZR (12 Weeks) n = 48	B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV n = 31	B11: GT2 NC GZR+UPR+RZR (12 Weeks) n = 31	B12: GT1 C GZR+UPR+RZR (8 Weeks) n = 35	B13: GT1 C GZR+UPR+RZR (12 Weeks) n = 40	B14: GT2 C GZR+UPR+RZR (12 Weeks) n = 15	B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV n = 16	16: GT2 C GZR+UPR+RZR (16 Weeks) n = 26
Value	60.9	83.3	56.3	71.4	73.9	60.9	62.3	86.7	75.0	68.8	72.9	80.6	71.0	57.1	72.5	53.3	81.3	69.2

Population analysed: All randomized participants who received at least 1 dose of study drug are included.

Primary outcome: Percentage of Participants Discontinuing From Study Treatment Due to an AE

Time frame: Up to 16 weeks. Number. Unit: Percentage of Participants

Measure	A1: GT1 NC GZR+UPR+EBR (8 Weeks) n = 23	A2: GT1 NC GZR+UPR+RZR (8 Weeks) n = 24	A3: GT2 NC GZR+UPR+EBR (8 Weeks) n = 16	A4: GT2 NC GZR+UPR+RZR (8 Weeks) n = 14	A5: GT1 NC GZR+UPR+EBR (8 Weeks) n = 23	A6: GT1 NC GZR+UPR+RZR (8 Weeks) n = 23	B6: GT1 NC GZR+UPR+RVR (8 Weeks) n = 30	A7: GT2 NC GZR+UPR+EBR (8 Weeks) n = 15	A8: GT2 NC GZR+UPR+RZR (8 Weeks) n = 16	B8: GT2 NC GZR+UPR+RZR (8 Weeks) n = 16	B9: GT1 NC GZR+UPR+RZR (12 Weeks) n = 48	B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV n = 31	B11: GT2 NC GZR+UPR+RZR (12 Weeks) n = 31	B12: GT1 C GZR+UPR+RZR (8 Weeks) n = 35	B13: GT1 C GZR+UPR+RZR (12 Weeks) n = 40	B14: GT2 C GZR+UPR+RZR (12 Weeks) n = 15	B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV n = 16	16: GT2 C GZR+UPR+RZR (16 Weeks) n = 26
Value	0	0	0	0	0	0	0	0	0	0	0	6.5	0	0	2.5	0	12.5	0

Population analysed: All randomized participants who received at least 1 dose of study drug are included.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 18 weeks (14 days after completing treatment). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A1: GT1 NC GZR+UPR+EBR (8 Weeks)	0 of 23 (0%)	13 of 23 (56.5%)	Not reported
A2: GT1 NC GZR+UPR+RZR (8 Weeks)	1 of 24 (4.2%)	19 of 24 (79.2%)	Not reported
A3: GT2 NC GZR+UPR+EBR (8 Weeks)	1 of 16 (6.3%)	10 of 16 (62.5%)	Not reported
A4: GT2 NC GZR+UPR+RZR (8 Weeks)	1 of 14 (7.1%)	10 of 14 (71.4%)	Not reported
A5: GT1 NC GZR+UPR+EBR (8 Weeks)	0 of 23 (0%)	15 of 23 (65.2%)	Not reported
A6: GT1 NC GZR+UPR+RZR (8 Weeks)	0 of 23 (0%)	13 of 23 (56.5%)	Not reported
A7: GT2 NC GZR+UPR+EBR (8 Weeks)	0 of 15 (0%)	13 of 15 (86.7%)	Not reported
A8: GT2 NC GZR+UPR+RZR (8 Weeks)	0 of 16 (0%)	12 of 16 (75%)	Not reported
B6: GT1 NC GZR+UPR+RVR (8 Weeks)	0 of 30 (0%)	18 of 30 (60%)	Not reported
B8: GT2 NC GZR+UPR+RZR (8 Weeks)	1 of 16 (6.3%)	11 of 16 (68.8%)	Not reported
B9: GT1 NC GZR+UPR+RZR (12 Weeks)	0 of 48 (0%)	35 of 48 (72.9%)	Not reported
B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBVMax 62 Characters...	2 of 31 (6.5%)	24 of 31 (77.4%)	Not reported
B11: GT2 NC GZR+UPR+RZR (12 Weeks)	0 of 31 (0%)	19 of 31 (61.3%)	Not reported
B12: GT1 C GZR+UPR+RZR (8 Weeks)	1 of 35 (2.9%)	19 of 35 (54.3%)	Not reported
B13: GT1 C GZR+UPR+RZR (12 Weeks)	3 of 40 (7.5%)	26 of 40 (65%)	Not reported
B14: GT2 C GZR+UPR+RZR (12 Weeks)	0 of 15 (0%)	8 of 15 (53.3%)	Not reported
B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV	0 of 16 (0%)	13 of 16 (81.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28802814Lawitz E, Buti M, Vierling JM, Almasio PL, Bruno S, Ruane PJ, Hassanein TI, Muellhaupt B, Pearlman B, Jancoriene L, Gao W, Huang HC, Shepherd A, Tannenbaum B, Fernsler D, Li JJ, Grandhi A, Liu H, Su FH, Wan S, Dutko FJ, Nguyen BT, Wahl J, Robertson MN, Barr E, Yeh WW, Plank RM, Butterton JR, Yoshida EM. Safety and efficacy of a fixed-dose combination regimen of grazoprevir, ruzasvir, and uprifosbuvir with or without ribavirin in participants with and without cirrhosis with chronic hepatitis C virus genotype 1, 2, or 3 infection (C-CREST-1 and C-CREST-2, part B): two randomised, phase 2, open-label trials. Lancet Gastroenterol Hepatol. 2017 Nov;2(11):814-823. doi: 10.1016/S2468-1253(17)30163-2. Epub 2017 Aug 10.
Derived from this study: PubMed 28802816Gane EJ, Pianko S, Roberts SK, Thompson AJ, Zeuzem S, Zuckerman E, Ben-Ari Z, Foster GR, Agarwal K, Laursen AL, Gerstoft J, Gao W, Huang HC, Fitzgerald B, Fernsler D, Li JJ, Grandhi A, Liu H, Su FH, Wan S, Zeng Z, Chen HL, Dutko FJ, Nguyen BT, Wahl J, Robertson MN, Barr E, Yeh WW, Plank RM, Butterton JR, Esteban R. Safety and efficacy of an 8-week regimen of grazoprevir plus ruzasvir plus uprifosbuvir compared with grazoprevir plus elbasvir plus uprifosbuvir in participants without cirrhosis infected with hepatitis C virus genotypes 1, 2, or 3 (C-CREST-1 and C-CREST-2, part A): two randomised, phase 2, open-label trials. Lancet Gastroenterol Hepatol. 2017 Nov;2(11):805-813. doi: 10.1016/S2468-1253(17)30159-0. Epub 2017 Aug 10.
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 Grazoprevir, Uprifosbuvir and Elbasvir 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 10 inclusion and 26 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 23 Jul 2019. 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 21 Dec 2017). 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 Completing Treatment (SVR12) (time frame: Up to 28 weeks). 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 NCT02332707, which also lists 2 linked publications.

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 23 Jul 2019.