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A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic Genotype 1 Hepatitis C Infection Who Failed Prior Standard Treatment.

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic Genotype 1 Hepatitis C Infection Who Failed Prior Standard Treatment.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2015

At a glance

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

    • 31 Aug 2018 Biomarkers information updated
    • 05 Dec 2013 According to ClinicalTrials.gov, the duration for the treatment (placebo + peginterferon alfa-2a + ribavirin) is changed from 12 weeks to 16 weeks and duration for the treatment (peginterferon alfa-2a + ribavirin) is changed from 36 weeks to 32 weeks.
    • 30 Apr 2013 Results, including patient outcomes stratified by previous type or virological failure, presented at the 23rd European Congress of Clinical Microbiology and Infectious Diseases.
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