NCT02759315 is a Phase 2 clinical trial of Uprifosbuvir 450 mg in Hepatitis C, Chronic, sponsored by Merck Sharp & Dohme LLC.

Who is sponsoring NCT02759315?

NCT02759315 is sponsored by Merck Sharp & Dohme LLC.

What drugs are being tested in NCT02759315?

Interventions in NCT02759315: Uprifosbuvir 450 mg, Ruzasvir 60 mg.

What condition does NCT02759315 study?

NCT02759315 studies Hepatitis C, Chronic.

Is NCT02759315 still recruiting?

NCT02759315 is currently terminated. Last updated 26 June 2019.

Are results published for NCT02759315?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-06-26 · How we verify

NCT02759315

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy and Safety of Uprifosbuvir (MK-3682) With Ruzasvir (MK-8408) in Adults With Chronic Hepatitis C Genotype 1, 2, 3, 4, 5 or 6 Infection (MK-3682-035)

Terminated Phase 2 Results posted Last updated 26 June 2019

What this trial tests

Phase 2 trial testing Uprifosbuvir 450 mg in Hepatitis C, Chronic in 160 participants. Terminated before completion.

Timeline

3 May 2016

Primary endpoint
27 July 2017

16 November 2017

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	160
Start date	3 May 2016
Primary completion	27 July 2017
Estimated completion	16 November 2017

Drugs / interventions tested

Uprifosbuvir 450 mg — full drug profile →
Ruzasvir 60 mg — full drug profile →

Conditions studied

Hepatitis C, Chronic — all drugs for Hepatitis C, Chronic →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Hepatitis C, Chronic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) Primary · Week 24 (12 weeks after completing study therapy)

The percentage of participants in each arm achieving SVR12 was determined. SVR12 was defined as HCV ribonucleic acid (RNA) levels in plasma \< lower limit of quantification (LLOQ) 12 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.

Group	Value	95% CI
GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg	97.1	89.9 – 99.6
GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg	100.0	87.7 – 100.0
GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg	76.9	60.7 – 88.9
GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg	90.0	68.3 – 98.8
GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg	66.7	9.4 – 99.2

Percentage of Participants With ≥1 Adverse Events (AEs) Primary · Up to Week 14 (up to 2 weeks after completing study therapy)

The percentage of participants experiencing an AE during the treatment period and first 2 weeks of follow-up was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Group	Value	95% CI
GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg	52.2
GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg	44.8
GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg	43.6
GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg	55.0
GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg	66.7

Percentage of Participants Withdrawing From Study Therapy Due to an AE Primary · Up to Week 12

The percentage of participants discontinuing from study therapy during the treatment period was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Group	Value	95% CI
GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg	0.0
GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg	3.4
GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg	0.0
GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg	5.0
GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg	0.0

Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24) Secondary · Week 36 (24 weeks after completing study therapy)

The percentage of participants in each arm achieving SVR24 was determined. SVR24 was defined as HCV RNA levels in plasma \< LLOQ 24 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. For SVR24, participants with GT1 infection were separated into GT1a or GT1b infection.

Group	Value	95% CI
GT1a: Uprifosbuvir 450 mg + Ruzasvir 60 mg	96.2
GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg	100.0
GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg	75.0
GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg	90.0
GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg	66.7
GT1b: Uprifosbuvir 450 mg + Ruzasvir 60 mg	100.0

Percentage of Participants With Virologic Failure (VF) Secondary · 12 weeks after the end of all study therapy (24 weeks)

The percentage of participants in each arm experiencing VF was determined. VF was defined as: 1) non-response (HCV RNA detected at end of treatment without HCV RNA \< LLOQ while on treatment); 2) rebound (\>1 log 10 IU/mL increase in HCV RNA from nadir while on treatment); 3) virologic breakthrough (HCV RNA ≥LLOQ after being \<LLOQ on treatment); or 4) relapse (HCV RNA ≥LLOQ after end of all study therapy after being undetectable at end of treatment); virologic failure could occur either on-treatment or relapse post-treatment. For VF, participants with GT1 infection were separated into GT1a or

Group	Value	95% CI
GT1a: Uprifosbuvir 450 mg + Ruzasvir 60 mg	3.7
GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg	0.0
GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg	23.1
GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg	5.0
GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg	33.3
GT1b: Uprifosbuvir 450 mg + Ruzasvir 60 mg	0.0

Percentage of Participants With Baseline Resistance-Associated Substitutions (RAS) Achieving SVR12 Secondary · 12 weeks after the end of all study therapy (24 weeks)

The percentage of participants in each arm with baseline RAS achieving SVR12 was determined. Analysis of RAS in NS5A or NS5B at baseline was determined. SVR12 was defined as HCV RNA levels in plasma \< LLOQ 24 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.

Group	Value	95% CI
GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg	97.1
GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg	100.0
GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg	97.4
GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg	94.7
GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg	66.6

Percentage of Participants With ≥1 Events of Clinical Interest (ECIs) Primary · Up to Week 14 (up to 2 weeks after completing study therapy)

The percentage of participants with ECIs was determined. ECIs were defined as the following: 1) an overdose of study drug; 2) first instance of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>500 IU/L; 3) first instance of ALT or AST \>3x nadir and \>3x upper limit of normal (ULN); 4) first instance of estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m\^2; or 4) first instance of serum creatinine \>1.3x ULN and elevated from baseline.

Overdose

Group	Value	95% CI
GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg	4.3
GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg	3.4
GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg	5.1

Non-overdose ECI

Group	Value	95% CI
GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg	2.8
GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg	2.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 36 weeks (up to 24 weeks after completing study treatment). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg

Serious: 4/69 (6%)

Deaths: 0/69

GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg

Serious: 0/29 (0%)

Deaths: 0/29

GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg

Serious: 1/39 (3%)

Deaths: 1/39

GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg

Serious: 2/20 (10%)

Deaths: 0/20

GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg

Serious: 0/3 (0%)

Deaths: 0/3

Serious adverse events (13 terms)

Reaction	System	GT1: Uprifosbuvir 450 mg +…	GT2: Uprifosbuvir 450 mg +…	GT3: Uprifosbuvir 450 mg +…	GT4: Uprifosbuvir 450 mg +…	GT6: Uprifosbuvir 450 mg +…
Melaena	Gastrointestinal disorders	—	—	—	—	—
Oesophagitis haemorrhagic	Gastrointestinal disorders	—	—	—	—	—
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—
Drug withdrawal syndrome	General disorders	—	—	—	—	—
Arthritis bacterial	Infections and infestations	—	—	—	—	—
Staphylococcal bacteraemia	Infections and infestations	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Accidental overdose	Injury, poisoning and procedural complications	—	—	—	—	—
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Sciatica	Nervous system disorders	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—
Schizophrenia	Psychiatric disorders	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—

Other adverse events (12 terms — click to expand)

Reaction	System	GT1: Uprifosbuvir 450 mg +…	GT2: Uprifosbuvir 450 mg +…	GT3: Uprifosbuvir 450 mg +…	GT4: Uprifosbuvir 450 mg +…	GT6: Uprifosbuvir 450 mg +…
Fatigue	General disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Accidental overdose	Injury, poisoning and procedural complications	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—

Most-reported serious reactions: Melaena, Oesophagitis haemorrhagic, Upper gastrointestinal haemorrhage, Drug withdrawal syndrome, Arthritis bacterial, Staphylococcal bacteraemia, Urinary tract infection, Accidental overdose.

Data from ClinicalTrials.gov NCT02759315 adverse events section.

Sponsor's own description

This study is an open-label, multi-center trial to evaluate the novel 2-drug regimen of uprifosbuvir (MK-3682) 450 mg and ruzasvir (MK-8408) 60 mg in participants with chronic hepatitis C virus (HCV) genotype (GT)1, GT2, GT3, GT4, GT5, or GT6 infection. The impact of the study treatment regimen on the percentage of participants with undetectable HCV ribonucleic acid \[RNA\] 12 weeks after completing study treatment (SVR12) will be evaluated.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

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.
Lawitz E, Gane E, Feld JJ, Buti M, et al · · 2019 · cited 9× · PMID 31108015 · DOI 10.1111/jvh.13132
Efficacy and safety of ruzasvir 60 mg and uprifosbuvir 450 mg for 12 weeks in adults with chronic hepatitis C virus genotype 1, 2, 3, 4 or 6 infection.
Lawitz E, Poordad F, Anderson LJ, Vesay M, et al · · 2019 · cited 6× · PMID 30739366 · DOI 10.1111/jvh.13079
Efficacy and safety of direct-acting antiviral regimen for patients with hepatitis C virus genotype 2: a systematic review and meta-analysis.
Lei PK, Liu Z, Ung COL, Hu H. · · 2024 · PMID 39350091 · DOI 10.1186/s12876-024-03414-5

Verify or expand the search:

Other recruiting trials for Hepatitis C, Chronic

Currently open trials in the same condition.

NCT04014179 — Enhancing Hepatitis C Testing and Treatment Among People Who Inject Drugs Attending Needle and Syringe Programs · NA · active not recruiting
NCT04943588 — Treating Hepatitis C in Pakistan. Strategies to Avoid Resistance to Antiviral Drugs · recruiting
NCT03520660 — People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents · Phase 4 · active not recruiting
NCT03200379 — Nation-wide Hepatitis C Virus (HCV) Registry in Taiwan · recruiting

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02759315 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 26 June 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02759315.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing