An Exploratory Phase IIa, Randomized, Open-Label Trial to Investigate the Efficacy and Safety of 12 Weeks or 24 Weeks of TMC435 in Combination With PSI-7977 (GS7977) With Or Without Ribavirin in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Subjects

Trial Profile

An Exploratory Phase IIa, Randomized, Open-Label Trial to Investigate the Efficacy and Safety of 12 Weeks or 24 Weeks of TMC435 in Combination With PSI-7977 (GS7977) With Or Without Ribavirin in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Subjects

Completed
Phase of Trial: Phase II

Latest Information Update: 17 Apr 2016

At a glance

  • Drugs Simeprevir (Primary) ; Sofosbuvir (Primary) ; Ribavirin
  • Indications Hepatitis C
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Acronyms COSMOS
  • Sponsors Janssen R&D Ireland
  • Most Recent Events

    • 17 Apr 2016 Results assessing NS3 resistance-associated variants from COSMOS and OPTIMIST-1/-2 studies (n=53) presented at The International Liver Congress™ 2016
    • 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.
    • 28 Jul 2014 Results published in the Lancet.
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