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 launched prior to new drug approvals in order to answer important questions for regulatory bodies and pharmaceutical partners. 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. The unique study design allows for a better understanding of the natural history of the disease with its 3 years of retrospective analysis of NASH patients at TARGET sites and subsequent prospective enrollment duration of at least 5 years. In addition to the general steering committee, pediatric and endocrinology working groups have been formed.
Initial Goals include:
- Establish an understanding of the current natural history of NASH at academic and community medical centers
- Examine populations under-represented in phase II-III clinical trials
- Evaluate optimal duration and combination of NASH therapies to achieve clinical response and clinical remission
Launched: August, 2016
Targeted number of patients: 15,000
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