Fatty Liver Clinical Trial
The purpose of this study is to determine whether cysteamine will effectively reduce or reverse the biologic markers of steatohepatitis in patients.
Status | Completed |
Enrollment | 13 |
Est. completion date | January 2010 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years and older |
Eligibility |
Inclusion Criteria: - Biopsy confirmed diagnosis of non-alcoholic steatohepatitis (within past 12 months) - Ages 10 yrs and older - Must swallow tablets on a regular basis - ALT level >60 iu/L Exclusion Criteria: - Subjects with known hypersensitivity to cysteamine - History, currently or within the past 3 months, of the following conditions: - Pancreatitis - Inflammatory bowel disease - Malabsorption - Unstable heart disease, e.g., myocardial infarction, heart failure, arrhythmias. - Unstable diabetes mellitus - Any bleeding disorder. - Zollinger-Ellison syndrome - Malignant disease - Subjects whom maybe pregnant or have health issues that make it unsafe for them participate, or whose concomitant medical problems preclude them from committing to the study schedule. - No specific NASH medical therapy for 3 months such as vitamin E, s-adenosyl methionine or metformin or other NAFLD study drugs. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Diego School of Medicine General Clinic Research Center | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Joel Lavine | Raptor Pharmaceuticals Corp. |
United States,
Angulo P, Lindor KD. Non-alcoholic fatty liver disease. J Gastroenterol Hepatol. 2002 Feb;17 Suppl:S186-90. Review. — View Citation
Contos MJ, Sanyal AJ. The clinicopathologic spectrum and management of nonalcoholic fatty liver disease. Adv Anat Pathol. 2002 Jan;9(1):37-51. Review. — View Citation
Dohil R, Fidler M, Barshop BA, Gangoiti J, Deutsch R, Martin M, Schneider JA. Understanding intestinal cysteamine bitartrate absorption. J Pediatr. 2006 Jun;148(6):764-9. — View Citation
Fishbein MH, Miner M, Mogren C, Chalekson J. The spectrum of fatty liver in obese children and the relationship of serum aminotransferases to severity of steatosis. J Pediatr Gastroenterol Nutr. 2003 Jan;36(1):54-61. — View Citation
Gahl WA, Thoene JG, Schneider JA. Cystinosis. N Engl J Med. 2002 Jul 11;347(2):111-21. Review. — View Citation
Lu SC. Regulation of glutathione synthesis. Curr Top Cell Regul. 2000;36:95-116. Review. — View Citation
Lyons J, Rauh-Pfeiffer A, Yu YM, Lu XM, Zurakowski D, Tompkins RG, Ajami AM, Young VR, Castillo L. Blood glutathione synthesis rates in healthy adults receiving a sulfur amino acid-free diet. Proc Natl Acad Sci U S A. 2000 May 9;97(10):5071-6. — View Citation
Mitchell JR, Thorgeirsson SS, Potter WZ, Jollow DJ, Keiser H. Acetaminophen-induced hepatic injury: protective role of glutathione in man and rationale for therapy. Clin Pharmacol Ther. 1974 Oct;16(4):676-84. — View Citation
Pamuk GE, Sonsuz A. N-acetylcysteine in the treatment of non-alcoholic steatohepatitis. J Gastroenterol Hepatol. 2003 Oct;18(10):1220-1. — View Citation
Prescott LF, Critchley JA. The treatment of acetaminophen poisoning. Annu Rev Pharmacol Toxicol. 1983;23:87-101. Review. — View Citation
Prescott LF, Park J, Proudfoot AT. Cysteamine, L-methionine and D-penicillamine in paracetamol poisoning. J Int Med Res. 1976;4(4 Suppl):112-7. — View Citation
Prescott LF, Stewart MJ, Proudfoot AT. Cysteamine or N-acetylcysteine for paracetamol poisoning? Br Med J. 1978 Apr 1;1(6116):856-7. — View Citation
Prescott LF. Haemodialysis in paracetomol self-poisoning. Lancet. 1972 Sep 23;2(7778):652. — View Citation
Skelly AH, Arcury TA, Gesler WM, Cravey AJ, Dougherty MC, Washburn SA, Nash S. Sociospatial knowledge networks: appraising community as place. Res Nurs Health. 2002 Apr;25(2):159-70. — View Citation
Wu G, Fang YZ, Yang S, Lupton JR, Turner ND. Glutathione metabolism and its implications for health. J Nutr. 2004 Mar;134(3):489-92. Review. — View Citation
* Note: There are 15 references in all — Click here to view all references
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Primary | Normalization or >50% of Serum ALT Levels From Baseline | 6 months | No |
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