An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-333 and Ribavirin (RBV) in Treatment-Naive and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection.

Trial Profile

An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-333 and Ribavirin (RBV) in Treatment-Naive and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection.

Completed
Phase of Trial: Phase II

Latest Information Update: 04 Apr 2017

At a glance

  • Drugs Dasabuvir (Primary) ; Paritaprevir (Primary) ; Ritonavir (Primary) ; Ribavirin
  • Indications Hepatitis C
  • Focus Therapeutic Use
  • Acronyms Co-Pilot
  • Sponsors Abbott Laboratories
  • Most Recent Events

    • 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.
    • 07 Jan 2015 The primary endpoint has been changed from safety and antiviral activity to percentage of participants with HCV RNA suppressed below the lower limit of detection along with change in trial focus from TU, AR to TU as per ClinicalTrials.gov.
    • 21 Nov 2012 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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