April 20, 2009
Phase 3 study of clevudine voluntarily terminated for hepatitis BPharmasset announced that after a discussion with its independent Data Safety Monitoring Board (DSMB) and the FDA, the company has decided to voluntarily terminate its Phase 3 QUASH studies of clevudine for the treatment of chronic hepatitis B (HBV) infection. Pharmasset recently became aware of a number of spontaneous serious adverse event reports and events of special interest (myopathy or muscle weakness associated with creatine kinase elevations) in patients receiving clevudine as prescribed therapy for hepatitis B in South Korea. Given the number and severity of cases observed in South Korea, Pharmasset concluded it was in the best interest of patients to terminate the studies at this time.
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