An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Ombitasvir (OBV), Paritaprevir (PTV), Ritonavir (RTV) With or Without Dasabuvir (DSV) and With or Without Ribavirin (RBV) in Pediatric Subjects With Genotype 1 or 4 Chronic Hepatitis C Virus (HCV) Infection (ZIRCON)

Trial Profile

An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Ombitasvir (OBV), Paritaprevir (PTV), Ritonavir (RTV) With or Without Dasabuvir (DSV) and With or Without Ribavirin (RBV) in Pediatric Subjects With Genotype 1 or 4 Chronic Hepatitis C Virus (HCV) Infection (ZIRCON)

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 23 Apr 2017

At a glance

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

    • 14 Apr 2017 Planned End Date changed from 1 Dec 2021 to 17 Sep 2021.
    • 19 Dec 2016 Planned End Date changed from 1 Jan 2023 to 1 Dec 2021.
    • 18 Jul 2016 The primary endpoint sustained virologic response 24 weeks (SVR24) has changed to sustained virologic response 12 weeks (SVR12) and the time frame of primary endpoint has been changed from 36 weeks or 48 weeks to 24 weeks or 36 weeks. The treatment arm Genotype 4, with compensated cirrhosis 24 weeks of treatment has been changed to 12 weeks of treatment. Planned patient number has also decreased.
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