Results of a phase 4 trial of Tacrobell® in liver transplantation patients: A multicenter study in South Korea

Young Dong Yu, Sung Gyu Lee, Jae Won Joh, Choon Hyuck Kwon, Dong Gu Kim, Kyung Suk Suh, Nam Jun Lee, Shin Hwang, Chul Soo Ahn, Ki Hun Kim, Deok Bog Moon, Tae Yong Ha, Gi Won Song, Dong Hwan Jung

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8 Citations (Scopus)

Abstract

Background/Aims: This 26-week pilot study was performed in de novo liver transplant recipients to evaluate the efficacy of tacrobell capsule as an immunosuppressant drug after living donor liver transplant patients by determining the rate of acute cellular rejection after its use and evaluating its safety after transplantation. Methodology: From October 2005 to July 2007, 57 patients from four major medical centers in Seoul, South Korea were enrolled in the study. This open-label, non-comparative, multicenter pilot study lasted 26 weeks and assigned patients to receive tacrobell and corticosteroid after liver transplantation. Tacrobell (0.05mg/kg/day, bid) and methylprednisolone were injected either on the day of the operation or on postoperative day one. A retrospective matched control group consisting of living donor liver transplant recipients at one center (Asan medical center) was used for comparison. Results: The rate of acute cellular rejection with tacrobell after 26 weeks of administration was 0.0% (95% CI, 0.0%-6.27%), which was below our hypothesized 36%. The most common drug-related adverse events included endocrine/nutritional disorders followed by gastrointestinal and hepatobiliary disorders. No patients died during the study period. The side effect profile of this drug was no different than other tacrolimus based immunosuppressants. Conclusions: Although our study was based on a low risk population and had a short-term follow up, we conclude that tacrobell, as a generic tacrolimus, can be considered safe and effective in liver transplant patients.

Original languageEnglish
Pages (from-to)357-363
Number of pages7
JournalHepato-gastroenterology
Volume59
Issue number114
DOIs
Publication statusPublished - 2012 Mar
Externally publishedYes

Keywords

  • Acute rejection
  • Liver transplantation
  • Tacrobell

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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    Yu, Y. D., Lee, S. G., Joh, J. W., Kwon, C. H., Kim, D. G., Suh, K. S., Lee, N. J., Hwang, S., Ahn, C. S., Kim, K. H., Moon, D. B., Ha, T. Y., Song, G. W., & Jung, D. H. (2012). Results of a phase 4 trial of Tacrobell® in liver transplantation patients: A multicenter study in South Korea. Hepato-gastroenterology, 59(114), 357-363. https://doi.org/10.5754/hge11472