NCT00040027

Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (planned)
• Sponsor: SciClone Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chronic hepatitis C infection is one of the leading causes of chronic liver disease in the United States. Approximately one-third of patients with hepatitis C infection develop cirrhosis of the liver, which can lead to liver failure or liver cancer. The current treatment for hepatitis C infection in previously untreated patients is successful in only about half of patients. There is no established therapy for non-responders. This is a randomized, double-blinded, multicenter trial to determine the effectiveness of thymosin alpha 1 (thymalfasin) 1.6 mg twice weekly plus PEGinterferon alfa-2a 180 ug/wk compared to placebo plus PEGinterferon alfa-2a in adults with chronic hepatitis C without cirrhosis who are non-responders to previous treatment with interferon or interferon plus ribavirin. The definition of non-response requires a positive HCV RNA test at the end of a course of at least 12 weeks of therapy. Patients will receive treatment for 12 months, and will be followed-up for a further 6 months after the end of therapy.

Conditions

• Hepatitis C
• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	thymalfasin (thymosin alpha 1) + PEGinterferon alfa-2a
DRUG	placebo + PEGinterferon alfa-2a

Timeline

• Start date: 2002-04-01
• First posted: 2002-07-04
• Last updated: 2008-01-15

Locations

48 sites across 2 countries: United States, Puerto Rico