This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Hepatitis C is a virus that lives in the liver (of infected patients) and can cause cirrhosis and hepatocellular carcinoma (HCC, liver cancer). Alpha fetoprotein (AFP) is a """"""""tumor marker"""""""" The blood level of AFP increases in some patients with HCC. SAMe is a """"""""drug"""""""" that is sold as a dietary supplement in the United States (available without a prescription) and as a prescription drug in other countries. It has been used in Europe for more than 10 years and has been for sale in the US for more than 5 years. The purpose of this study is to determine whether the experimental drug, S-adenosyl-l-methionine disulphate p-toluene-sulfonate (SAMe, pronounced Sam-ee), will reduce the blood level of AFP in patients with hepatitis C cirrhosis and mildly elevated AFP. The proposed study is a Phase II, randomized, placebo-controlled, multicenter clinical trial. Approximately 116 patients with hepatitis C cirrhosis and mildly elevated AFP will be randomized to treatment with either SAMe or placebo (1:1) for 24 weeks. Funding for the clinical trial is provided by the National Cancer Institute.
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