Oltipraz therapy in patients with liver fibrosis or cirrhosis: A randomized, double-blind, placebo-controlled phase II trial

Sang Geon Kim, Young Mi Kim, Jong Young Choi, Joon Yeol Han, Jeong Won Jang, Se Hyun Cho, Soon Ho Um, Chae Yoon Chon, Dong Hoo Lee, Ja June Jang, Eunsil Yu, Young Sok Lee

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14 Citations (Scopus)

Abstract

Objectives Oltipraz, a cancer chemopreventive agent, has an anticirrhotic effect in animals. A phase II trial was designed to investigate the preliminary efficacy of oltipraz therapy in liver fibrosis or cirrhosis. Methods Of 83 patients who were randomized to receive placebo, oltipraz 60 mg bid or oltipraz 90 mg qd for 24 weeks, 68 completed the study without any major protocol violation. Pre- and post-treatment liver biopsies, and blood fibrosis markers were assessed. Key findings Twenty-four weeks of oltipraz treatment showed no significant differences in the proportions of patients showing an improvement in histological outcomes, including Ishak fibrosis score. In the oltipraz 60 mg bid group, there was a trend of decreases in hepatic collagen area and plasma transforming growth factor-β1 (TGF-β1, a blood fibrosis marker) levels from baseline to week 24. In the per-protocol population (n = 68), decreases in plasma TGF-β1 correlated with those in the Ishak fibrosis score, suggesting that circulating TGF-β1 serves a possible indicator for fibrosis treatment. Conclusions No significant differences in liver histological outcomes were seen among the three treatment groups in this 24-week pilot study. Our finding indicates an association between TGF-β1 repression and improvement in the histological index of fibrosis.

Original languageEnglish
Pages (from-to)627-635
Number of pages9
JournalJournal of Pharmacy and Pharmacology
Volume63
Issue number5
DOIs
Publication statusPublished - 2011 May

Keywords

  • TGF-β1
  • clinical trial
  • liver fibrosis and cirrhosis
  • oltipraz

ASJC Scopus subject areas

  • Pharmacology
  • Pharmaceutical Science

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    Kim, S. G., Kim, Y. M., Choi, J. Y., Han, J. Y., Jang, J. W., Cho, S. H., Um, S. H., Chon, C. Y., Lee, D. H., Jang, J. J., Yu, E., & Lee, Y. S. (2011). Oltipraz therapy in patients with liver fibrosis or cirrhosis: A randomized, double-blind, placebo-controlled phase II trial. Journal of Pharmacy and Pharmacology, 63(5), 627-635. https://doi.org/10.1111/j.2042-7158.2011.01259.x