Low real-world eligibility rates for nonalcoholic steatohepatitis patients for phase 3 clinical trial criteria application in a large academic health system.

ABSTRACT:

Objective

Nonalcoholic steatohepatitis (NASH) is the most common liver disease in the USA. Clinical trials have stringent study criteria which may limit real-world generalizability. Thus, we studied whether a real-world, university-based cohort of patients could be eligible for a pivotal phase 3 NASH clinical trial.

Methods

We queried Yale-New Haven Health System electronic medical records for patients with a diagnosis of NASH from 2013 to 2017. Of those who received liver biopsy, we extracted demographic, clinical, laboratory, and biopsy data. We compared patient characteristics to enrollment criteria of the Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment.

Results

Of 14 403 patients with NASH, 478 (3.3%) comp

SUBMITTER: Ilagan-Ying YC 

PROVIDER: S-EPMC7674230 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature