A Phase 2 interventional study of oltipraz and placebo in Liver Fibrosis and Liver Cirrhosis, sponsored by HK inno.N Corporation. Completed at 2 sites in Korea, Republic of. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-08-11.
Sponsored by HK inno.N Corporation · Phase 2, Interventional, and Treatment
This study investigated the effectiveness and safety of oltipraz therapy in treating patients with cirrhosis induced by chronic hepatitis type B or C.
Oltipraz [5-(2-pyrazinyl)-4-methyl-1,2-dithiol-3-thione] has been extensively studied as a cancer chemopreventive agent. Comprehensive mechanistic and phase IIa studies supported the notion that oltipraz exerts chemopreventive effects, as supported by Phase IIa human clinical studies of oltipraz on cancer chemoprevention, conducted in Qidong, China. Hepatic stellate cells cause synthesis of large quantities of extracellular matrix. Transforming growth factor beta1 (TGF-beta1), as a key fibrogenic mediator for fibrogenesis after injuries through deposition of extracellular matrix and inhibition of collagenase activity in the liver, is associated with the regulation of cell growth and differentiation and causes synthesis of extracellular matrix proteins and cellular receptors for matrix proteins. Previously, we reported the effectiveness of oltipraz in regeneration of cirrhotic liver, which includes reduction of the intensities of liver fibrotic and cirrhotic nodules, elimination of accumulated extracellular matrix, and regeneration of cirrhotic liver in animal models. Oltipraz completely resolves fibrosis in the cirrhotic liver, thereby improving viability. TGF-beta1 signaling plays an important role in liver fibrogenesis and cirrhosis as evidenced by receptor knockout experiments. No therapeutic agent that is active in interrupting TGF-beta1 signaling is available, proposing that C/EBP serve as a molecular target for the treatment of liver cirrhosis.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 81 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →HK inno.N Corporation is the lead sponsor of 99 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: placebo
Drug: oltipraz
60mg bid 90mg qd
Ishak fibrosis score
Time frame: 24 weeks
The Modified Knodell's HAI score
Time frame: 24 weeks
Child-Pugh score
Time frame: 24 weeks
This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.
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HK inno.N Corporation