A Phase 3, Open-Label Study With Daclatasvir And Asunaprevir (DUAL) for Subjects With Genotype 1b Chronic Hepatitis C (HCV) Infection Who Are Intolerant or Ineligible to Interferon Alfa Therapies With or Without Ribavirin

Trial Profile

A Phase 3, Open-Label Study With Daclatasvir And Asunaprevir (DUAL) for Subjects With Genotype 1b Chronic Hepatitis C (HCV) Infection Who Are Intolerant or Ineligible to Interferon Alfa Therapies With or Without Ribavirin

Completed
Phase of Trial: Phase III

Latest Information Update: 28 May 2017

At a glance

  • Drugs Asunaprevir (Primary) ; Daclatasvir (Primary)
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 28 May 2017 According to a Bristol-Myers Squibb media release, based on the data from this trial and data from other studies conducted outside of China, the China Food and Drug Administration (CFDA) has approved a direct-acting antiviral regimen Daklinza (daclatasvir) and Sunvepra(asunaprevir), for the treatment of treatment-naive or -experienced patients, with or without compensated cirrhosis, infected with genotype 1b chronic hepatitis C virus (HCV).
    • 22 Feb 2016 Results from this trial were presented at the Asian Pacific Association for the Study of the Liver Conference (APASL), according to a Bristol-Myers Squibb media release.
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