A DOUBLE-BLIND, PLACEBO-CONTROLLED, PILOT TRIAL OF THYMOSIN-ALPHA FORTHE TREATMENT OF CHRONIC HEPATITIS-C

A randomized, double-blind, placebo-controlled trial was performed to evaluate the efficacy and safety of thymosin alpha1 (alpha(1)) in trea ting chronic hepatitis C. Nineteen Italian patients with chronic activ e hepatitis C, proven by biopsy were randomly assigned to receive a si x month course of thymosin alpha(1) (900 mu g/m(2) of body surface are a twice weekly) or a placebo. All had HCV-RNA in their serum (by PCR), with serum ALT levels more than double the upper limit of the normal range for at least six months before enrollment. After treatment, pati ents were followed for an additional six months. All patients complete d the trial. One patient treated with thymosin alpha(1), but no patien t in the placebo group, normalized serum ALT levels by the end of the treatment. This patient, however, relapsed at the sixth month of the f ollow-up. Overall, there were no significant changes in mean serum ALT levels in either group during the treatment or follow-up period. No p atient cleared HCV-RNA. No side effects were reported except for local discomfort at the injection sites, reported by some patients treated with thymosin alpha(1). In conclusion, this regimen of thymosin alpha( 1) is not effective in the treatment of chronic hepatitis C.