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S3-E40.5 – From the Vault: Why Cirrhosis Matters In Clinical Trial Strategy

This episode discusses the unique role NASH cirrhosis studies can play in clinical trial design, particularly in the transition from biopsy as gold standard to a post-biopsy world. Stephen Harrison starts this conversation by discussing why we focus on NASH cirrhosis and goes on to review the recent presentation of results from the REVERSE study on obeticholic acid. Jörn Schattenberg and Mazen Noureddin add their perspectives to the conversation.

Episode 40 focuses on lean NASH, and Michelle Long notes that many patients with lean NASH are diagnosed in the Emergency Department when they present with symptoms of decompensating cirrhosis. This conversation from November 2021 considers cirrhotic patients from a different perspective: their uniquely valuable role in clinical trial strategy as the world evolves beyond biopsy as gold standard.

From the Vault: Why Cirrhosis Matters In Clinical Trial Strategy

S2-E54.1 – Inside the Patient-Focused Drug Development meeting: Stories of Personal Experiences

Mazen Noureddin notes during this week’s episode that when he identifies lean NASH patients, he encourages them strongly to participate in clinical trials. This conversation also looks at the value of cirrhosis studies in clinical trial design, although from a quite different perspective.

From the initial description of this conversation: In this conversation, Stephen Harrison starts by pointing out that non-cirrhotic NASH trials and NASH cirrhosis trials differ significantly in goals, endpoints and patient severity. From there, he dives into the NASH cirrhosis trial group with his review of REVERSE, which Vlad Ratziu presented at AASLD. Jörn Schattenberg and Mazen Noureddin also comment on design of this trial. The conversation focuses on two issues: who is the optimal patient for a NASH cirrhosis trial and what is the most appropriate attainable endpoint and, therefore, clinical design? On the optimal patient issue, the group agrees the ideal patient is a well-compensated cirrhotic, because the presence of portal hypertension makes the entire healing issue so much more complex. There was less agreement on the optimal design question.

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