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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
Phase 2 trial testing BMS-650032 in Chronic Hepatitis C in 320 participants. Completed in 31 July 2015.
31 March 2014
Quick facts
| Lead sponsor | Bristol-Myers Squibb |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 320 |
| Start date | 30 November 2011 |
| Primary completion | 31 March 2014 |
| Estimated completion | 31 July 2015 |
| Sites | 32 locations across France, Puerto Rico, United States |
Drugs / interventions tested
- BMS-650032 — full drug profile →
- BMS-790052 — full drug profile →
- BMS-791325 — full drug profile →
- Ribavirin — full drug profile →
Conditions studied
- Chronic Hepatitis C — all drugs for Chronic Hepatitis C →
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):
-
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT01455090
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Hepatitis C
Currently open trials in the same condition.
- NCT06180590 — The Efficacy of Vosevi in Treating DAA-experienced Patients · recruiting
- NCT03993925 — Enhancing Access to Care for Chronic Hepatitis C Infected Populations in Hong Kong · active not recruiting
Other Bristol-Myers Squibb trials
Trials by the same sponsor.
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- NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder · Phase 3 · not yet recruiting
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- 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)
- Trial protocol + status: ClinicalTrials.gov NCT01455090 (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: 27 April 2017
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