Study Background
♦ Primary sclerosing cholangitis (PSC) is a chronic fibrosing cholangiopathymarked by heterogeneous clinical presentation
♦ Fibrosis progression is the primary histologic endpoint in two Phase 3 clinical trials of PSC (ClinicalTrials.gov NCT03872921 and NCT03890120)
♦ Current histologic staging systems for PSC, including the Nakanuma
classification, are predictive of clinical events, but have only fair interobserver agreement and may require specialized staining procedures
♦ Variability in histologic evaluation in patients with PSC may hinder disease
staging and confound clinical trial results Travis et al.
