Last reviewed · How we verify

NCT01455090

Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications

Completed Phase 2 Last updated 27 April 2017
What this trial tests

Phase 2 trial testing BMS-650032 in Chronic Hepatitis C in 320 participants. Completed in 31 July 2015.

Timeline
30 November 2011
Primary endpoint
31 March 2014
31 July 2015

Quick facts

Lead sponsorBristol-Myers Squibb
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment320
Start date30 November 2011
Primary completion31 March 2014
Estimated completion31 July 2015
Sites32 locations across France, Puerto Rico, United States

Drugs / interventions tested

Conditions studied

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

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

Sponsor's own description

The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA \< LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 \& Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin

Publications & conference data

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

  1. Efficacy of an interferon- and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection.
    Everson GT, Sims KD, Rodriguez-Torres M, Hézode C, et al · · 2014 · cited 147× · PMID 24184132 · DOI 10.1053/j.gastro.2013.10.057
  2. Hepatitis C drugs: the end of the pegylated interferon era and the emergence of all-oral interferon-free antiviral regimens: a concise review.
    Yau AH, Yoshida EM. · · 2014 · cited 51× · PMID 25229466 · DOI 10.1155/2014/549624
  3. Preclinical characterization of BMS-791325, an allosteric inhibitor of hepatitis C Virus NS5B polymerase.
    Lemm JA, Liu M, Gentles RG, Ding M, et al · · 2014 · cited 43× · PMID 24733465 · DOI 10.1128/aac.02495-13
  4. Hepatitis C virus protease inhibitor-resistance mutations: our experience and review.
    Wu S, Kanda T, Nakamoto S, Imazeki F, et al · · 2013 · cited 30× · PMID 24379619 · DOI 10.3748/wjg.v19.i47.8940
  5. Randomized, placebo-controlled, single-ascending-dose study of BMS-791325, a hepatitis C virus (HCV) NS5B polymerase inhibitor, in HCV genotype 1 infection.
    Sims KD, Lemm J, Eley T, Liu M, et al · · 2014 · cited 25× · PMID 24733462 · DOI 10.1128/aac.02579-13
  6. NS5A Sequence Heterogeneity and Mechanisms of Daclatasvir Resistance in Hepatitis C Virus Genotype 4 Infection.
    Zhou N, Hernandez D, Ueland J, Yang X, et al · · 2016 · cited 24× · PMID 26170396 · DOI 10.1093/infdis/jiv379

Verify or expand the search:

Other recruiting trials for Chronic Hepatitis C

Currently open trials in the same condition.

Other Bristol-Myers Squibb trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT01455090.

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