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 the TARGET-NASH 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 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 NAFLD at academic and community medical centers

  • Evaluate NAFLD treatment regimens being used in clinical practice

  • Examine populations underrepresented in phase II-III clinical trials

  • Evaluate optimal duration and combination of NAFLD therapies to achieve clinical response and clinical remission

  • Examine liver histology

  • Estimate adverse event frequency and severity and describe management practices

  • Evaluate the impact of NAFLD therapies on medical co-morbidities

Launched:

August 2016

 

ENROLLMENT GOAL:

Up to 15,000

CUSTOM REAL-WORLD EVIDENCE SOLUTIONS

Looking for a custom RWE solution? With our broad and extensive real-world database encompassing a multitude of diseases, TARGET has proven experience in providing easier, more feasible ways to generate and analyze patient data in real settings. Let us work with you to create a complete data solution built specifically for your RWE needs. 

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 Chair)
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