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A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

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Trial Profile

A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Oct 2021

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At a glance

  • Drugs Telaprevir (Primary) ; Peginterferon alfa-2a; Ribavirin
  • Indications Hepatitis C
  • Focus Pharmacogenomic; Registrational; Therapeutic Use
  • Acronyms OPTIMIZE
  • Sponsors Janssen Infectious Diseases BVBA

Most Recent Events

  • 28 Apr 2013 Results assessing efficacy in patients with different stages of fibrosis and with or without cirrhosis presented at the 48th Annual Meeting of the European Association for the Study of the Liver.
  • 28 Apr 2013 Results reporting efficacy by IL28B genotype presented at the 48th Annual Meeting of the European Association for the Study of the Liver.
  • 16 Oct 2012 Primary endpoint 'Sustained-virological-response-rate', defined as undetectable HCV RNA at week 24 post-treatment, has been met according to a Janssen Research and Development media release.

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