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Hepatotoxicity Clinical Research Network: The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for the establishment of a Clinical Research Network that will focus upon the elucidation of the clinical features and pathogenesis of drug and toxin-induced liver injury, a common cause of acute liver disease, morbidity and mortality. Drug and toxin-induced liver injury can be mild and transient, resulting merely in a transient elevation in serum aminotransferase levels, but also can be severe, protracted and even life-threatening, resulting in acute liver failure. Most severe adverse hepatic toxic reactions are unpredictable, idiosyncratic and uncommon. In addition, attribution of the hepatic injury to the medication can be unclear and complicated by the presence other possible causes of liver disease. Liver injury from drugs is often not predicted by pre-clinical testing in laboratory animals and most medications that cause severe liver disease in humans cause little or no hepatic injury in animals. Furthermore, the increasing use of complementary and alternative medicines (CAM) has led to additional cases of toxin-induced liver disease that are often more challenging and confusing to evaluate. Complementary medications often consist of mixtures of herbs and other active compounds that may not be well characterized or studied. These features make diagnosis of drug and toxin-induced liver injury difficult and analysis of the causes of hepatotoxicity limited. Yet drug-induced liver disease is becoming an increasing important problem in medicine. With an increasing proportion of the U.S. population taking medications as well as CAM therapies, the clinical burden of hepatotoxicity is only going to worsen. Hepatotoxicity is the single, most common adverse drug reaction that leads to drug withdrawal and or refusal of approval by the Food and Drug Administration (FDA). Such withdrawals or refusals have enormous financial implications for the pharmaceutical industry and can result in the loss of availability of an effective therapy because of a rare occurrence of toxicity in a small proportion of patients who take the medication. The intent of this Request for Applications (RFA) is to establish and maintain the infrastructure required for a Hepatotoxicity Clinical Research Network consisting of a group of interactive Clinical Centers (CCs) and a Data Coordinating Center (DCC). The primary objective of the Hepatotoxicity Clinical Research Network is to develop standardized instruments to identify and fully characterize bona fide cases of drug, CAM and toxin- induced liver injury to allow for analysis of the epidemiology and clinical spectrum of hepatotoxicity and to obtain biological samples for study of the pathogenesis of hepatotoxicity using biochemical, serological and genetic techniques. The recent development of powerful methods of genetic analysis and pharmacogenomics promises to provide important insights into the mechanisms of drug actions and drug toxicities. These techniques requires the availability of carefully defined cases of liver injury to both create and test hypothesis on metabolic pathways that predispose to liver injury. This initiative will expand our understanding of the mechanisms of drug and toxin- induced liver injury and provide the basis for more effective and safe medical therapies. This is a one-time solicitation to support a feasibility phase of a Hepatotoxicity Clinical Research Network for 3 years.
Income Security and Social Services Health Food and Nutrition
Type of Opportunity:
Funding Opportunity Number:
Type of Funding:
Digestive Diseases and Nutrition Research
Current Application Deadline:
No deadline provided
Original Application Deadline:
Nov 13, 2002
Jul 12, 2002
Dec 13, 2002
Dec 13, 2002
Total Program Funding:
Maximum Federal Grant Award:
Minimum Federal Grant Award:
Expected Number of Awards:
Cost Sharing or Matching:
Applicants Eligible for this Grant
State governments County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Individuals For profit organizations other than small businesses Small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification)