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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 07 Jul 2010

At a glance

  • Drugs Interferon alfacon-1 (Primary) ; Ribavirin (Primary)
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Acronyms DIRECT-1; DIRECT-2
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top