A double-blind, placebo-controlled, pilot trial of thymosin alpha 1 for the treatment of chronic hepatitis C.

A randomized, double-blind, placebo-controlled trial was performed to evaluate the efficacy and safety of thymosin alpha 1 (alpha 1) in treating chronic hepatitis C. Nineteen Italian patients with chronic active hepatitis C, proven by biopsy were randomly assigned to receive a six month course of thymosin alpha 1 (900 micrograms/m2 of body surface area 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.