Limited Competition: Alcohol-associated Hepatitis Clinical Network Integrated Treatment Clinical Trials Clinical Centers (U01-Clinical Trial required)

closed

The purpose of this limited competition Notice of Funding Opportunity (NOFO) is to leverage the established clinical infrastructure of the previously funded program on Late Phase Clinical Trials and Observational Studies in Alcoholic Hepatitis. The existing program of AH Clinical and Translational Network, hereafter termed AlcHepNet, has been sponsored by the NIAAA since 2012 and was renewed in 2018. In the next cycle the program will consist of up to six Clinical Study Sites and one Data Coordinating Center to conduct an integrated treatment clinical trial that incorporates active treatment of Alcohol Use Disorder (AUD) with treatment of alcohol-associated liver disease (ALD). The targeted patient population will include severe alcohol-associated hepatitis (sAH) and decompensated alcohol-associated cirrhosis (deAC). Through this Request for Applications (RFA), U01 Collaborative Cooperative Agreement applications are sought to conduct an investigator-initiated common protocol integrated ALD-AUD treatment clinical trial and site-specific ancillary studies. Each Clinical Center application must consist of a multidisciplinary investigative team that includes a hepatologist and an addiction medicine specialist, and be comprised of primary and if necessary, subsites with a track record of successful enrollment in past clinical trials.