Nonalcoholic Steatohepatitis (NASH)

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 short term, it gives 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's 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 trials. Arun Sanyal, MD

According to the latest studies, between 30 and 40% of adults in the U.S. have nonalcoholic fatty liver disease and about 3 to 12% of those adults have NASH. The TARGET-NASH study launched prior to new drug approvals to answer important questions for regulatory bodies and pharmaceutical partners, given the limited information available.

The data collected in this study is critical in providing a baseline to measure the impact of current management and new therapies on medical co-morbidities, natural history, and hepatic, cardiovascular, and endocrine-associated outcomes.  TARGET-NASH also provides a robust, meticulously-documented cohort that can immediately be used to collect effectiveness and safety data upon new drug approvals.

Our 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. Pediatric and endocrinology TARGET-NASH working groups have been formed in addition to the general steering committee. 

 

Study Goals:

  • 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 remission

Launched:

August 2016

 

ENROLLMENT GOAL:

15,000

TARGET-NASH Steering Committee

Kenneth Cusi, MD (Co-Chair)
Chief of the Division of Endocrinology, Diabetes and Metabolism, Gainesville, FL

Arun Sanyal, MD (Co-Chair)
Chair of the Division of Gastroenterology, Hepatology and Nutrition, Richmond, VA

Brent Tetri, MD (Co-Chair)
Director, Division of Gastroenterology & Hepatology, St. Louis, MO

Miriam Vos, MD, MSPH (Pediatrics Lead)
Assistant Professor of Pediatrics, Atlanta, GA

Michael Roden, MD
Chair of Endocrinology and Metabolic Diseases, Düsseldorf, Germany

A. Sidney Barritt, MD, MSCR
Associate Professor of Medicine, Division of Gastroenterology & Hepatology, Chapel Hill, NC

Rohit Loomba, MD
Professor of Medicine, Division of Gastroenterology, San Diego, CA

Philip Newsome, PhD, FRCPE
Director, Centre for Liver Research, Birmingham, UK

Samuel Klein, MD
William H. Danforth Professor of Medicine and Nutritional Science, St. Louis, MO

Vincent Wong, MBChB (Hons), MD, FRCP, FHKCP, FHKAM
Professor, Department of Medicine and Therapeutics, Hong Kong