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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)

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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Dasabuvir (Primary) ; Ombitasvir/paritaprevir/ritonavir (Primary) ; Ribavirin
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Acronyms SAPPHIRE-II
  • Sponsors Abbott Laboratories; AbbVie

    • Most Recent Events

    • 01 Dec 2017 Results of post-hoc pooled analysis of this and other five phase III trials, published in the Infectious Diseases and Therapy.
    • 04 Apr 2017 Results of exposure-safety response analysis using data (n=2998) from patients of five phase II and six phase III studies (Co-Pilot, Navigator, M13-386, Aviator, M14-103, SAPPHIRE-I, SAPPHIRE-II, TURQUOISE-II, PEARL-II, PEARL-III, PEARL-IV), published in the Clinical Drug Investigation Journal.
    • 23 Sep 2016 Results (n=4189) of seven trials ( PEARL-II,PEARL-III,PEARL-IV,TURQUOISE-II,SAPPHIRE-I,SAPPHIRE-II and one phase 2 trial) published in the British Journal of Clinical Pharmacology (2016).

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