A Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Antiviral Activity of the Combination of ABT-450 with Ritonavir (ABT-450/r), ABT-267, and ABT-333 With and Without Ribavirin in Treatment-Experienced Subjects with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (PEARL-II)

Trial Profile

A Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Antiviral Activity of the Combination of ABT-450 with Ritonavir (ABT-450/r), ABT-267, and ABT-333 With and Without Ribavirin in Treatment-Experienced Subjects with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (PEARL-II)

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Apr 2017

At a glance

  • Drugs Dasabuvir (Primary) ; Ombitasvir/paritaprevir/ritonavir (Primary) ; Ribavirin
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Acronyms PEARL-II
  • Sponsors AbbVie
  • Most Recent Events

    • 23 Apr 2017 Other planned location include Puerto Rico.
    • 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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