TORONTO, ON--(Marketwired - November 15, 2016) -
- Arun Sanyal, MD, Professor of Medicine and Chairman of Gastroenterology Division, Virginia Commonwealth University School of Medicine
- Claudia Filozof, MD, PhD Executive, Medical Director in CVM/ER Therapeutic Area, Covance
- Arie Regev, MD, Head of the Safety Advisory Hub, Eli Lilly and Company
- Tammy McIver, MSc, CStat, Senior Manager, Biostatistics and Statistical Programming, Covance
NASH: Who are the Patients with a Progressive Disease?
Nonalcoholic fatty liver disease (NAFLD) is the most common etiology of chronic liver disease and cirrhosis in developed countries. In spite of the progress in the understanding of pathophysiology there are still many uncertainties in the diagnostic approaches and evaluation, and there is no approved therapy for NASH. The frequency and clinical correlates of NAFLD phenotypes, the progression from fatty liver (FL) to steatohepatitis (or regression from NASH to FL) and the progression or improvement in hepatic fibrosis remain uncertain. In addition to specific genetic predispositions associated with more severe disease in subsets of patients (e.g. PNPLA3 I148M mutation) both disease activity and disease stage affect progression to cirrhosis. In this webinar, Dr. Arun Sanyal will discuss risk factors for disease progression and the implications in clinical development and the need of pharmacological intervention.
Detection and Assessment of Drug Induced Liver Injury (DILI) in NASH Clinical Trials
Drug induced liver injury (DILI) is a leading cause of acute liver failure and transplantation in western countries; and although rare, represents a serious clinical problem due to its unpredictable nature and possibly fatal course. There is no clear evidence of increased risk of DILI in NASH patients, however patients with advanced NASH may have worse outcome when DILI occurs. Patients with NASH have, in general, mild to moderate elevations in liver aminotransferases. However, Hy's law may be difficult to apply to all NASH patients, especially those with baseline ALT>3x ULN. Dr. Arie Regev will address specific questions related to the detection, assessment and monitoring of DILI in NASH patients.
Adaptive Trial Design in a NASH Development Program
The increasing prevalence, the associated health burden and the lack of approved therapy for patients with NASH represents a substantial unmet medical need. Unfortunately, the long and asymptomatic natural history of the disease, the uncertainties about the disease progression, the fact that most patients are undiagnosed, and the requirement for sequential liver biopsies, creates substantial challenges for clinical development. Adaptive trial designs are being increasingly looked at as a way to streamline the development path and optimize the time to development without compromising on the quality of the evidence needed to establish the efficacy and safety of therapeutic agents. Dr. Claudia Filozof will discuss the strategic framework of applying a seamless adaptive design in a NASH development program. Tammy McIver will describe the statistical considerations.
For more information or to register for this complimentary event, visit: Hot Topics in Non-Alcoholic Steatohepatitis (NASH).
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