Efficacy outcomes
liver stiffness, Spleen stiffness, cirrhosis
CIRRHOSIS
The change from baseline in spleen stiffness was inconclusive due to a high proportion of invalid measurements (31%) and technical and biological variability (Supplemental Table S2, Spleen stiffness in patients with Child -Pugh class A cirrhosis. Data are presented as mean±SD, with individual values represented. Abbreviations: BID, twice daily; EoT, end of treatment.The 2 highest doses of BI 685509 treatment decreased the portal–systemic shunt fraction of the HepQuant SHUNT test from baseline to day 27 (Figure Change in portal–systemic shunt fraction in patients with Child–Pugh class A cirrhosis as measured by the HepQuant SHUNT test. Data are presented as mean±SD. Abbreviations: BID, twice daily.At baseline, liver stiffness was higher in patients with CP-B cirrhosis (median 28.8–46.7 kPa) compared with patients with CP-A cirrhosis (median 23.0–29.3 kPa; Table Overall, no relevant differences between patient groups or treatment groups or relevant changes from baseline were observed for any assessed biomarkers, composite scores, or patient-reported outcomes (Supplemental Table S2, 