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
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History