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Thymosin α 1 treatment of chronic hepatitis B: results of a phase III multicentre, randomized, double‐blind and placebo‐controlled study
Author(s) -
Mutchnick M. G.,
Lindsay K. L.,
Schiff E. R.,
Cummings G. D.,
Appelman H. D.,
Peleman R. R.,
Silva M.,
Roach K. C.,
Simmons F.,
Milstein S.,
Gordon S. C.,
Ehrinpreis M. N.
Publication year - 1999
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1046/j.1365-2893.1999.00181.x
Subject(s) - hbeag , medicine , gastroenterology , hbsag , placebo , hepatitis b virus , hepatitis b , randomization , immunology , randomized controlled trial , virus , pathology , alternative medicine
Previous clinical trials have suggested that thymosin α 1 (Tα 1 ), an immunomodulatory peptide, may be effective in the treatment of chronic hepatitis B (CHB). The aim of this study was to determine the efficacy of Tα 1 in a multicentre, placebo‐controlled and double‐blind study of 97 patients with serum hepatitis B virus (HBV) DNA‐ and hepatitis B e antigen (HBeAg)‐positive CHB. Patients who had been hepatitis B surface antigen (HBsAg) positive for at least 12 months entered a 3‐month screening period prior to randomization. Forty‐nine patients received Tα 1 (1.6 mg) and 48 patients received placebo, twice weekly for 6 months, and were followed‐up for an additional 6 months. At inclusion, both groups were comparable for age, gender, histological grading, and aminotransferase and HBV DNA levels. A complete response to treatment, defined as a sustained serum HBV DNA‐negative status (two negative results at least 3 months apart) during the 12‐month study, with negative HBV DNA and HBeAg values at month 12, was seen in seven (14%) patients given Tα 1 and in two (4%) patients treated with placebo ( P = 0.084). Five (10%) patients given Tα 1 and four (8%) patients given placebo exhibited a delayed response (defined as sustained serum HBV DNA negativity achieved after the 12‐month study period with negative HBV DNA and HBeAg values at the last assessment). A total of 12 (25%) patients given Tα 1 and six (13%) patients given placebo showed a sustained loss of HBV DNA with a negative HBeAg value during or following the 12‐month study period ( P < 0.11). These results do not confirm observations of treatment efficacy reported in other clinical studies.