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Home » INTERMUNE COMPLETES ENROLLMENT OF PHASE III TRIAL
INTERMUNE COMPLETES ENROLLMENT OF PHASE III TRIAL
July 12, 2005
InterMune, announced the completion of patient enrollment in its Phase III clinical trial of daily Infergen in combination with ribavirin for the treatment of patients chronically infected with hepatitis C virus (HCV) who have failed to respond to a previous course of therapy with pegylated interferon alfa-2 plus ribavirin.
Results from independent investigator studies of daily Infergen (interferon alfacon-1) plus ribavirin in the U.S. and in Europe suggest sustained virologic response (SVR) rates that are substantially higher than alternative treatments for PEG- nonresponders.
This randomized, open-label study known as the DIRECT (Daily-dose consensus Interferon and Ribavirin: Effect of Combination Therapy) trial has enrolled 514 PEG-nonresponders at 40 leading medical centers in the U.S. The trial is designed to compare the safety and efficacy of daily Infergen plus ribavirin to observation without treatment, the most frequently adopted approach to treating PEG-nonresponders.
The primary endpoint is the proportion of patients with SVR, defined as the absence of detectable HCV RNA in serum 72 weeks after the initiation of treatment. To date, the trial's data monitoring committee has noted no safety concerns.
KEYWORDS Drug Pipeline Alert
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