CMHC Pulse Blog

This focus on recruiting NASH patients with moderate fibrosis (F2-F3) creates one of the key challenges of NASH studies – enrolling subjects at a suitable rate, 25-45% of NAFLD patients typically have no fibrosis, approximately 30% have fibrosis stage F1, 5-10% have cirrhosis (F4), leaving only ~25% with fibrosis stage F2 to F3.

Cardiometabolic Chronicle: Based on your experience with NASH trials, is there any outreach to other physician specialties that are in the forefront the NASH epidemic to better identify patients who can be candidates for these trials?

Dr. Roche: This is a very important point. Historically, NASH clinical trials have been supported primarily by hepatologists or gastroenterologists. However, the field needs to involve those physicians who see the majority of diagnosed and undiagnosed NASH patients, i.e., primary care physicians and endocrinologists. This can be achieved by increasing general awareness of NASH amongst these physicians and their patients. ICON is working to expand our network of NASH qualified clinicians and sites by helping them link up with specialists with the appropriate skills and equipment (e.g., MR imaging, radiologist for biopsies and Fibroscan to measure liver stiffness) as a means of optimizing enrollment.

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