NCT02673489 is a Phase 3 clinical trial of DCV in Hepatitis C, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT02673489?

NCT02673489 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT02673489?

Interventions in NCT02673489: DCV, SOF, RBV.

What condition does NCT02673489 study?

NCT02673489 studies Hepatitis C.

Is NCT02673489 still recruiting?

NCT02673489 is currently completed. Last updated 8 May 2018.

Are results published for NCT02673489?

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

Last reviewed 2018-05-08 · How we verify

NCT02673489

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

A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection

Completed Phase 3 Results posted Last updated 8 May 2018

What this trial tests

Phase 3 trial testing DCV in Hepatitis C in 106 participants. Completed in 26 May 2017.

Timeline

15 March 2016

Primary endpoint
2 March 2017

26 May 2017

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	106
Start date	15 March 2016
Primary completion	2 March 2017
Estimated completion	26 May 2017
Sites	19 locations across Canada, United States

Drugs / interventions tested

DCV — full drug profile →
SOF — full drug profile →
RBV — full drug profile →

Conditions studied

Hepatitis C — all drugs for Hepatitis C →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with Hepatitis C. 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 With Sustained Virologic Response (SVR12) Primary · Week 12

SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach.

Group	Value	95% CI
HCV Treatment Naive	92.6	82.1 – 97.9
HCV Treatment Experienced	75.0	53.3 – 90.2

Percentage of Participants Who Achieve SVR12 in the Presence and Absence of Baseline NS5A (Non-structural Protein 5A) Resistance-associated Polymorphisms Secondary · Week 12 (Follow-up period)

NS5A-Y93 Polymorphism: YES

Group	Value	95% CI
HCV Treatment Naive	85.7	42.1 – 99.6
HCV Treatment Experienced	0.0	0.0 – 97.5

NS5A-Y93 Polymorphism: NO

Group	Value	95% CI
HCV Treatment Naive	93.6	82.5 – 98.7
HCV Treatment Experienced	78.3	56.3 – 92.5

Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24 Secondary · At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment (24 weeks), Follow Up Week 4 (28 weeks), Follow Up Week 12 (36 weeks), Follow Up Week 24 (48 weeks)

HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria. SVR12 is based on Next Value Carried Backwards approach.

Week 1

Group	Value	95% CI
HCV Treatment Naive	14.8	6.6 – 27.1
HCV Treatment Experienced	12.5	2.7 – 32.4

Week 2

Group	Value	95% CI
HCV Treatment Naive	50.0	36.1 – 63.9
HCV Treatment Experienced	54.2	32.8 – 74.4

Week 4

Group	Value	95% CI
HCV Treatment Naive	92.6	82.1 – 97.9
HCV Treatment Experienced	75.0	53.3 – 90.2

Week 8

Group	Value	95% CI
HCV Treatment Naive	98.1	90.1 – 100.0
HCV Treatment Experienced	91.7	73.0 – 99.0

Week 12

Group	Value	95% CI
HCV Treatment Naive	92.6	82.1 – 97.9
HCV Treatment Experienced	87.5	67.6 – 97.3

Week 16

Group	Value	95% CI
HCV Treatment Naive	90.7	79.7 – 96.9
HCV Treatment Experienced	83.3	62.6 – 95.3

Week 20

Group	Value	95% CI
HCV Treatment Naive	94.4	84.6 – 98.8
HCV Treatment Experienced	83.3	62.6 – 95.3

Week 24

Group	Value	95% CI
HCV Treatment Naive	88.9	77.4 – 95.8
HCV Treatment Experienced	87.5	67.6 – 97.3

Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24 Secondary · At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment, Follow Up Week 4, Follow Up Week 12, Follow Up Week 24

Week 1

Group	Value	95% CI
HCV Treatment Naive	1.9	0.0 – 9.9
HCV Treatment Experienced	0.0	0.0 – 14.2

Week 2

Group	Value	95% CI
HCV Treatment Naive	11.1	4.2 – 22.6
HCV Treatment Experienced	12.5	2.7 – 32.4

Week 4

Group	Value	95% CI
HCV Treatment Naive	64.8	50.6 – 77.3
HCV Treatment Experienced	62.5	40.6 – 81.2

Week 8

Group	Value	95% CI
HCV Treatment Naive	94.4	84.6 – 98.8
HCV Treatment Experienced	83.3	62.6 – 95.3

Week 12

Group	Value	95% CI
HCV Treatment Naive	90.7	79.7 – 96.9
HCV Treatment Experienced	83.3	62.6 – 95.3

Week 16

Group	Value	95% CI
HCV Treatment Naive	90.7	79.7 – 96.9
HCV Treatment Experienced	79.2	57.8 – 92.9

Week 20

Group	Value	95% CI
HCV Treatment Naive	94.4	84.6 – 98.8
HCV Treatment Experienced	83.3	62.6 – 95.3

Week 24

Group	Value	95% CI
HCV Treatment Naive	88.9	77.4 – 95.8
HCV Treatment Experienced	83.3	62.6 – 95.3

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Overall: Daclatasvir(DCV) + Sofosbuvir(SOF) + Ribavirin(RBV)

Serious: 8/78 (10%)

Deaths: 0/78

HCV Treatment Naive

Serious: 4/54 (7%)

Deaths: 0/54

HCV Treatment Experienced

Serious: 4/24 (17%)

Deaths: 0/24

Serious adverse events (8 terms)

Reaction	System	Overall: Daclatasvir(DCV) …	HCV Treatment Naive	HCV Treatment Experienced
Accidental overdose	Injury, poisoning and procedural complications	—	—	—
Ascites	Gastrointestinal disorders	—	—	—
Chest discomfort	General disorders	—	—	—
Cholecystitis	Hepatobiliary disorders	—	—	—
Bronchiolitis	Infections and infestations	—	—	—
Streptococcal bacteraemia	Infections and infestations	—	—	—
Overdose	Injury, poisoning and procedural complications	—	—	—
Depression	Psychiatric disorders	—	—	—

Other adverse events (22 terms — click to expand)

Reaction	System	Overall: Daclatasvir(DCV) …	HCV Treatment Naive	HCV Treatment Experienced
Fatigue	General disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Irritability	Psychiatric disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Toothache	Gastrointestinal disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Anxiety	Psychiatric disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Gastroesophageal Reflux Disease	Gastrointestinal disorders	—	—	—
Pruritis Generalised	Skin and subcutaneous tissue disorders	—	—	—
Pyrexia	General disorders	—	—	—
Oral Herpes	Infections and infestations	—	—	—
Upper Respiratory Tract Infection	Infections and infestations	—	—	—

Most-reported serious reactions: Accidental overdose, Ascites, Chest discomfort, Cholecystitis, Bronchiolitis, Streptococcal bacteraemia, Overdose, Depression.

Data from ClinicalTrials.gov NCT02673489 adverse events section.

Sponsor's own description

The purpose of this study is to determine whether 24 weeks of Daclatasvir and Sofosbuvir with Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients with liver cirrhosis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Daclatasvir and sofosbuvir with ribavirin for 24 weeks in chronic hepatitis C genotype-3-infected patients with cirrhosis: a Phase III study (ALLY-3C).
Poordad F, Shiffman ML, Ghesquiere W, Wong A, et al · · 2019 · cited 7× · PMID 30382942 · DOI 10.3851/imp3278

Verify or expand the search:

Other recruiting trials for Hepatitis C

Currently open trials in the same condition.

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Other Bristol-Myers Squibb trials

Trials by the same sponsor.

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NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · 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 NCT02673489 (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 Bristol-Myers Squibb
Last refreshed: 8 May 2018

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/NCT02673489.

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