A randomized controlled trial of thymopentin therapy in patients with chronic hepatitis B

J Hepatol. 1994 Sep;21(3):361-6. doi: 10.1016/s0168-8278(05)80314-9.


Strategies of treatment of chronic hepatitis type B are currently based on the use of either antiviral or immunomodulatory agents. A randomized, controlled trial was performed to assess the safety and efficacy of 6-month thymopentin therapy in 30 patients with chronic hepatitis B. Inclusion criteria were biopsy-proven chronic hepatitis, elevated alanine aminotransferase and serum HBsAg and HBV-DNA positivity for at least 12 months. At the conclusion of the study (1 year), HBV-DNA was negative and alanine aminotransferase had normalized in 13% and 20% of treated cases and in 20% and 27% of controls. None of the ten treated and one of the nine control patients who were initially HBeAg positive subsequently cleared HBeAg. None became HBsAg negative. A histologic improvement was noted in 27% of the treated patients compared with 18% of controls. These results indicate that this regimen of thymopentin therapy is not effective in treating chronic hepatitis B.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Alanine Transaminase / blood
  • Chronic Disease
  • DNA, Viral / blood
  • DNA, Viral / genetics
  • Dose-Response Relationship, Drug
  • Female
  • Follow-Up Studies
  • Hepatitis B / drug therapy*
  • Hepatitis B / epidemiology
  • Hepatitis B Surface Antigens / blood
  • Hepatitis B virus / genetics
  • Humans
  • Male
  • Middle Aged
  • Thymopentin / adverse effects
  • Thymopentin / standards
  • Thymopentin / therapeutic use*


  • DNA, Viral
  • Hepatitis B Surface Antigens
  • Alanine Transaminase
  • Thymopentin