The patients must have failed to respond to injectable interferon, or relapsed after initially responding to injectable interferon, and will receive one of three different dosages of oral human interferon alpha or placebo.
The standard of care for chronic hepatitis C is high dose of human interferon alpha injected alone or in combination with ribavirin. Typically, only about 50% of hepatitis C patients respond to the standard of care. The trial is expected to start in the fourth quarter of 2007.
Approximately 170 million people are chronically infected with hepatitis C virus worldwide. There is no effective vaccine against hepatitis C virus. In addition to studies on hepatitis C, under the terms of the license and supply Agreement, CytoPharm will be testing oral interferon in human studies of chronic active hepatitis B patients and of influenza patients.