Thymosin Alpha 1 and PEG-Interferon for Treatment-Resistant Hepatitis C Cirrhosis
Thymosin Plus PEG-Interferon in Hepatitis C Patients With Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin
Background
Chronic hepatitis C infection (HCV) is a leading cause of chronic liver disease in the United States. Approximately one-third of patients with HCV develop cirrhosis (severe scarring of the liver), which can progress to liver failure or liver cancer. While current treatments for HCV are successful in about half of previously untreated patients, there remains a significant challenge for those who do not respond. This Phase 3 study addresses the critical knowledge gap: there is no established therapy for non-responders to standard interferon or interferon plus ribavirin treatments.
Study Design
Population
Patients with treatment-resistant hepatitis C cirrhosis who are non-responders to standard interferon or interferon plus ribavirin treatments.
Intervention
Thymalfasin in combination with PEGinterferon alfa-2a; dose, route, and duration not specified.
Outcome
The primary endpoint measured was the effectiveness of the combination therapy in this patient population, though the specific measure is not detailed.