TARGET-NASH is currently enrolling
TARGET-NASH
“TARGET-NASH is critical for the scientific and regulatory community as we prepare for the plethora of new agents for the treatment of NASH. In the immediate term, it will give us a critical understanding of NASH diagnosis and management in the real world- beyond the ivory tower, across multiple populations. In the longer term, it is the perfect platform to have a deep understanding of the safety and effectiveness of these new agents across populations not included or underrepresented in Phase 3 clinical trials.” – Arun Sanyal, MD
Given the limited information available regarding NASH epidemiology and the robust clinical pipeline, TARGET-NASH is launching prior to new drug approvals in order to answer important questions for regulatory bodies and pharmaceutical sponsors. Data collected will be critical in providing a baseline against which to measure the impact of current management and new therapies on medical co-morbidities, natural history, and hepatic, cardiovascular, and endocrine-associated outcomes. In addition, it will provide a robust, meticulously documented cohort that can immediately be used to collect effectiveness and safety data upon new drug approvals. In order to be able to better understand the natural history of the disease, the unique study design will encompass a retrospective analysis of NASH patients seen within the last 3 years at TARGET sites with subsequent transition to prospective enrollment including a follow-up duration of at least 5 years.
TARGET-NASH Steering Committee
Kenneth Cusi, MD (co-Chair)
Chief of the Division of Endocrinology, Diabetes and Metabolism at University of Florida
Arun Sanyal, MD (co-Chair)
Chair of the Division of Gastroenterology, Hepatology and Nutrition at Virginia Commonwealth University School of Medicine
Brent Tetri, MD (co-Chair)
Director, Division of Gastroenterology & Hepatology at St. Louis University School of Medicine
A. Sidney Barritt, MD
Associate Professor of Medicine, Division of Gastroenterology & Hepatology, University of North Carolina at Chapel Hill
Rohit Loomba, MD
Professor of Medicine, Division of Gastroenterology, University of California, San Diego
Philip Newsome, PhD, FRCPE
Director, Centre for Liver Research at Birmingham University
Samuel Klein, MD
William H. Danforth Professor of Medicine and Nutritional Science at Washington University School of Medicine
Miriam Vos, MD, MSPH, (Pediatrics Lead)
Associate Professor of Pediatrics, Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Emory University School of Medicine
Vincent Wong, MBChB (Hons), MD, FRCP, FHKCP, FHKAM
Professor, Department of Medicine and Therapeutics at The Chinese University of Hong Kong