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A Phase 3, Randomized, Open-Label Study of the Safety and Efficacy of Two Dose Levels of Interferon Alfacon-1 (Infergen, CIFN) Plus Ribavirin Administered Daily for 48 Weeks Versus No Treatment in Hepatitis C Infected Patients Who Are Nonresponders to Previous Pegylated Interferon Alfa Plus Ribavirin Therapy

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Trial Profile

A Phase 3, Randomized, Open-Label Study of the Safety and Efficacy of Two Dose Levels of Interferon Alfacon-1 (Infergen, CIFN) Plus Ribavirin Administered Daily for 48 Weeks Versus No Treatment in Hepatitis C Infected Patients Who Are Nonresponders to Previous Pegylated Interferon Alfa Plus Ribavirin Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Nov 2019

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At a glance

  • Drugs Interferon alfacon-1 (Primary) ; Ribavirin (Primary)
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Acronyms DIRECT-1; DIRECT-2
  • Sponsors Bausch Health Companies

    • Most Recent Events

    • 07 Jul 2010 Results from this trial aided the approval by the US FDA for the expanded labeling for use of INFERGEN in combination with ribavarin for the retreatment of chroninc hepatitis C.
    • 16 Jun 2009 Primary endpoint 'Sustained virological response rate' has been met.
    • 01 Jun 2009 Pooled results of DIRECT-1 and -2 published in Hepatology.
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