NCT02556086 is a Phase 2 clinical trial of Daclatasvir in Hepatitis C, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT02556086?

NCT02556086 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT02556086?

Interventions in NCT02556086: Daclatasvir, Sofosbuvir.

What condition does NCT02556086 study?

NCT02556086 studies Hepatitis C.

Is NCT02556086 still recruiting?

NCT02556086 is currently withdrawn. Last updated 19 January 2016.

Last reviewed 2016-01-19 · How we verify

NCT02556086

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

A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)

Withdrawn Phase 2 Last updated 19 January 2016

What this trial tests

Phase 2 trial testing Daclatasvir in Hepatitis C. Withdrawn.

Timeline

1 December 2015

Primary endpoint
1 June 2016

1 July 2017

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 December 2015
Primary completion	1 June 2016
Estimated completion	1 July 2017
Sites	17 locations across Canada, France

Drugs / interventions tested

Daclatasvir (DACLATASVIR) — full drug profile →
Sofosbuvir — 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.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Proportion of subjects with SVR12
Time frame: Post treatment follow-up week 12
SVR12 rate defined as HCV RNA \< LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects infected with HCV/HIV-1 coinfection genotype 1-4

Sponsor's own description

The purpose of the study is to determine if combination therapy with daclatasvir (DCV) and sofosbuvir (SOF) for 8 weeks is safe and effective in patients who have never been treated previously without liver cirrhosis who are chronically infected with hepatitis C virus (HCV)/HIV-1 Coinfection genotype (GT) 1, 2, 3, 4 patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Daclatasvir

Trials testing the same drug.

NCT04460443 — Sofosbuvir in Treatment of COVID 19 · Phase 2, PHASE3 · unknown
NCT04497649 — Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients · Phase 2, PHASE3 · unknown
NCT04019717 — Study of AT-527 in Combination With Daclatasvir in Subjects With Hepatitis C Virus (HCV) Infection · Phase 2 · completed
NCT03706898 — Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess th · Phase 1 · completed
NCT03487848 — Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infectio · Phase 2 · terminated

Other recruiting trials for Hepatitis C

Currently open trials in the same condition.

NCT06263829 — HCV Tappt Adherence Study · NA · recruiting
NCT06179498 — Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs · NA · recruiting
NCT06367465 — Feasibility and Acceptability of HCV Treatment in Pregnancy · recruiting
NCT05668780 — Buprenorphine Integration Research and Community Health · NA · active not recruiting
NCT05208697 — Tele-Harm Reduction · NA · active not recruiting

Other Bristol-Myers Squibb trials

Trials by the same sponsor.

NCT07441408 — Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre · Phase 4 · not yet recruiting
NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder · Phase 3 · not yet recruiting
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 NCT02556086 (US National Library of Medicine, public domain)
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: 19 January 2016

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/NCT02556086.

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