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Cited 18 time in webofscience Cited 18 time in scopus
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Oltipraz therapy in patients with liver fibrosis or cirrhosis: a randomized, double-blind, placebo-controlled phase II trial

Authors
Kim, Sang GeonKim, Young MiChoi, Jong YoungHan, Joon-YeolJang, Jeong WonCho, Se-HyunUm, Soon HoChon, Chae YoonLee, Dong HooJang, Ja-JuneYu, EunsilLee, Young Sok
Issue Date
May-2011
Publisher
Pharmaceutical Press
Keywords
clinical trial; liver fibrosis and cirrhosis; oltipraz; TGF-beta 1
Citation
Journal of Pharmacy and Pharmacology, v.63, no.5, pp.627 - 635
Indexed
SCIE
SCOPUS
Journal Title
Journal of Pharmacy and Pharmacology
Volume
63
Number
5
Start Page
627
End Page
635
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/13493
DOI
10.1111/j.2042-7158.2011.01259.x
ISSN
0022-3573
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.
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