Document Detail

Treatment of primary biliary cirrhosis with tetrathiomolybdate: results of a double-blind trial.
MedLine Citation:
PMID:  20171597     Owner:  NLM     Status:  MEDLINE    
The results of a double-blind trial of tetrathiomolybdate therapy and standard of care, versus placebo and standard of care treatment, in primary biliary cirrhosis patients are presented. Baseline studies of liver function, various safety variables, ceruloplasmin, a liver biopsy for histologic analysis, and for various cytokine analyses were carried out. Patients were observed every 4 months for up to 2 years of treatment by a hepatologist for clinical evaluation and repeat of all the baseline studies except liver biopsy, which was repeated at 2 years. The primary end points were improvement in 2 liver function tests and in 1 inflammatory cytokine. Fifteen placebo patients were followed for an average of 13 months, and 13 tetrathiomolybdate patients were followed for an average of 14 months. The predefined primary end points for efficacy were met. Tetrathiomolybdate was well tolerated. Because tetrathiomolybdate has been shown in numerous animal studies to inhibit autoimmune and inflammatory processes, and because primary biliary cirrhosis is an autoimmune attack on bile ducts, these positive findings on efficacy of tetrathiomolybdate therapy in primary biliary cirrhosis fit with the animal studies and suggest the need for a longer clinical trial to examine transplant-free survival.
Fred Askari; Dawna Innis; Robert B Dick; Guoqing Hou; Jorge Marrero; Joel Greenson; George J Brewer
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, Non-P.H.S.     Date:  2009-10-14
Journal Detail:
Title:  Translational research : the journal of laboratory and clinical medicine     Volume:  155     ISSN:  1878-1810     ISO Abbreviation:  Transl Res     Publication Date:  2010 Mar 
Date Detail:
Created Date:  2010-02-22     Completed Date:  2010-03-17     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101280339     Medline TA:  Transl Res     Country:  United States    
Other Details:
Languages:  eng     Pagination:  123-30     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2010 Mosby, Inc. All rights reserved.
Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI 48109-5720, USA.
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MeSH Terms
Alanine Transaminase / blood
Aspartate Aminotransferases / blood
Copper / blood
Double-Blind Method
Liver Cirrhosis, Biliary / drug therapy*,  immunology,  pathology
Middle Aged
Molybdenum / therapeutic use*
Transforming Growth Factor beta / blood
Tumor Necrosis Factor-alpha / blood
Grant Support
Reg. No./Substance:
0/Transforming Growth Factor beta; 0/Tumor Necrosis Factor-alpha; 16330-92-0/tetrathiomolybdate; 7439-98-7/Molybdenum; 7440-50-8/Copper; EC Aminotransferases; EC Transaminase
Comment In:
Transl Res. 2010 Mar;155(3):120-2   [PMID:  20171596 ]

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