Clinical trial NCT01178996 (phase 3, status: completed)
Conditions: chronic hepatitis c
ICD codes: B18.2, B18.0, B18.1, B18.8, B18.9, K71.3, K71.4
Drugs: ribavirin, placebo
SMILES: NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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