Thymosin Alpha-1 in Combination With Peg-Interferon Alfa- 2a and Ribavirin for the Therapy of Chronic Hepatitis C Nonresponsive to the Combination of IFN and Ribavirin.

Exclusion Criteria

• •1. Use of systemic corticosteroids within 6 months of entry
• •2. More than one previous course of therapy with PEGinterferon alpha plus ribavirin
• •3. Any other liver disease
• •4. Decompensated liver disease based on a history of hepatic encephalopathy, bleeding oesophageal varices, or ascites
• •5. Decompensate or advanced liver cirrhosis (ChildPugh B or C)
• •6. HIV infection diagnosed by HIV seropositivity and confirmed by Western blot
• •7. Insulin-dependent Diabetes Mellitus
• •8. Severe haemoglobinopathy
• •9. Positive liver and kidney microsomal auto antibodies
• •10. Positive anti thyroid antibodies
• •11. Pregnancy as documented by a urine pregnancy test
• •12. Alcohol or intravenous drug abuse within the previous 1 year
• •13. Patients who are in poor medical or psychiatric conditions, or who have any non-malignant systemic disease that, in the opinion of the Investigator, would make it unlikely that the patient could complete the study protocol
• •14. Any indication that the patient would not comply with the conditions of the study protocol
• •15. Previous treatment with thymosin alpha 1
• •16. Patients with known hypersensitivity to any PEGinterferon and or ribavirin
• •17. Patients with a history of severe depression that required either hospitalization or electroshock therapy or depression associated with suicide attempt
• •18. Simultaneous participation in another investigational drug study or participation in any clinical trial involving investigational drugs within 3 months before study entry
• •19. Presence of serious pulmonary or cardiovascular disorders