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An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal Disease (RUBY-I)

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Trial Profile

An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal Disease (RUBY-I)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Oct 2018

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At a glance

  • Drugs Dasabuvir (Primary) ; Ombitasvir/paritaprevir/ritonavir (Primary) ; Ribavirin
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Acronyms RUBY-I
  • Sponsors AbbVie

    • Most Recent Events

    • 05 Oct 2018 Results of pharmacokinetic analysis of the phase 3 RUBY-I and RUBY-II (CTP:247959,CTP:258283) trials published in the European Journal of Clinical Pharmacology.
    • 01 Dec 2017 Results of post-hoc pooled analysis of this and other five phase III trials, published in the Infectious Diseases and Therapy.
    • 07 Dec 2016 Status changed from active, no longer recruiting to completed.

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