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Phase 2, Open-Label Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Tolerability of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052) and Ribavirin (RBV) in Subjects With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation

Trial Profile

Phase 2, Open-Label Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Tolerability of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052) and Ribavirin (RBV) in Subjects With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 28 Nov 2018

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At a glance

  • Drugs Daclatasvir (Primary) ; Simeprevir (Primary) ; Ribavirin
  • Indications Hepatitis C
  • Focus Pharmacokinetics; Therapeutic Use
  • Acronyms SATURN
  • Sponsors Janssen R&D Ireland
  • Most Recent Events

    • 18 Jan 2018 Results of pooled post-hoc analysis assessing impact of pharmacokinetic interaction between simeprevir and concomitant medications by using data from nine studies (SONET, OPTIMIST-1, OPTIMIST-2, COMMIT, GALAXY, OSIRIS, IMPACT, PLUTO and SATURN) published in the British Journal of Clinical Pharmacology.
    • 24 Sep 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov
    • 08 Apr 2015 Results will be presented at The International Liver Congress 2015 of the European Association for the Study of the Liver (EASL), as per Janssen Sciences media release.
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