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.
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.
The purpose of the study was to determine safety and efficacy of 48 weeks treatment with
 Thymosin alpha 1 (Talpha1) in combination with pegylated interferon (PEGIFN) alpha2a and
 ribavirin (RBV) in adult patients with chronic hepatitis C (CHC) already treated with, and
 not responding to previous courses of PEGIFN alpha plus RBV combination therapy, in
 comparison with a concurrent group treated with PEG IFN alpha2a in combination with RBV and
 placebo.
Inclusion Criteria:

 1. Signed written informed consent

 2. Age 18

 3. Presence of HCV RNA measured by quantitative PCR

 4. Non responder to previous approved doses of therapy with PEGinterferon alpha plus
 ribavirin. Patients must have been treated for at least 12 weeks with documented HCV
 RNA quantitative not showing major of 2 log10 HCV RNA reduction or patients treated
 for at least 24 weeks with documented HCV RNA qualitative not showing a virological
 response (viral RNA clearance)

 5. Liver biopsy consistent with a diagnosis of chronic hepatitis C or histological
 cirrhosis. Biopsy will not be required if the patient can produce a biopsy performed
 within the year preceding the randomization day and was performed at least 6 months
 after the end of the latter course of therapy

 6. Wash-out period of at least 6 months from previous therapy with PEGinterferon alpha
 plus ribavirin

 7. Negative pregnancy test prior (no more than 24 hours) to first study medication dose

 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