Oltipraz therapy in patients with liver fibrosis or cirrhosis: a randomized, double-blind, placebo-controlled phase II trial
- Authors
- Kim, Sang Geon; Kim, Young Mi; Choi, Jong Young; Han, Joon-Yeol; Jang, Jeong Won; Cho, Se-Hyun; Um, Soon Ho; Chon, Chae Yoon; Lee, Dong Hoo; Jang, Ja-June; Yu, Eunsil; Lee, 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
- Pages
- 9
- Indexed
- SCI
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
2042-7158
- 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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- Appears in
Collections - 2. Clinical Science > Department of Gastroenterology and Hepatology > 1. Journal Articles
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