Thymosin α1 treatment of chronic hepatitis B

Results of a phase III multicentre, randomized, double-blind and placebo-controlled study

M. G. Mutchnick, K. L. Lindsay, Eugene R Schiff, G. D. Cummings, H. D. Appelman, R. R. Peleman, M. Silva, K. C. Roach, F. Simmons, S. Milstein, S. C. Gordon, M. N. Ehrinpreis

Research output: Contribution to journalArticle

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Abstract

Previous clinical trials have suggested that thymosin α1 (Tα1), 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 Tα1 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 Tα1 (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 Tα1 and in two (4%) patients treated with placebo (P = 0.084). Five (10%) patients given Tα1 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 Tα1 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.

Original languageEnglish
Pages (from-to)397-403
Number of pages7
JournalJournal of Viral Hepatitis
Volume6
Issue number5
DOIs
StatePublished - Sep 1 1999

Fingerprint

Thymosin
Chronic Hepatitis B
Placebos
Hepatitis B virus
Hepatitis B e Antigens
DNA
Therapeutics
Serum
Hepatitis B Surface Antigens
Random Allocation
Transaminases
Double-Blind Method
Clinical Trials

Keywords

  • Chronic hepatitis B
  • Thymosin
  • Treatment

ASJC Scopus subject areas

  • Hepatology
  • Virology

Cite this

Thymosin α1 treatment of chronic hepatitis B : Results of a phase III multicentre, randomized, double-blind and placebo-controlled study. / Mutchnick, M. G.; Lindsay, K. L.; Schiff, Eugene 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.

In: Journal of Viral Hepatitis, Vol. 6, No. 5, 01.09.1999, p. 397-403.

Research output: Contribution to journalArticle

Mutchnick, MG, Lindsay, KL, Schiff, ER, Cummings, GD, Appelman, HD, Peleman, RR, Silva, M, Roach, KC, Simmons, F, Milstein, S, Gordon, SC & Ehrinpreis, MN 1999, 'Thymosin α1 treatment of chronic hepatitis B: Results of a phase III multicentre, randomized, double-blind and placebo-controlled study', Journal of Viral Hepatitis, vol. 6, no. 5, pp. 397-403. https://doi.org/10.1046/j.1365-2893.1999.00181.x
Mutchnick, M. G. ; Lindsay, K. L. ; Schiff, Eugene 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. / Thymosin α1 treatment of chronic hepatitis B : Results of a phase III multicentre, randomized, double-blind and placebo-controlled study. In: Journal of Viral Hepatitis. 1999 ; Vol. 6, No. 5. pp. 397-403.
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abstract = "Previous clinical trials have suggested that thymosin α1 (Tα1), 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 Tα1 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 Tα1 (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 Tα1 and in two (4{\%}) patients treated with placebo (P = 0.084). Five (10{\%}) patients given Tα1 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 Tα1 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.",
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