WHO ICTRP trial

A study to test whether BI 685509 alone or in combination with empagliflozin…

JPRN-jRCT2031220376 · Japan Primary Registries Network (JPRN) · Recruiting

Key facts

Trial ID JPRN-jRCT2031220376
Public title A study to test whether BI 685509 alone or in combination with empagliflozin helps people with liver cirrhosis caused by viral hepatitis or non-alcoholic steatohepatitis (NASH) who have high blood pressure in the portal vein (main vessel going to the liver)
Scientific title Randomised, open-label and parallel group trial to investigate the effects of oral BI 685509 alone or in combination with empagliflozin on portal hypertension after 8 weeks treatment in patients with clinically significant portal hypertension (CSPH) incompensated cirrhosis
Primary sponsor Kutsunai Mitsuru
Registry Japan Primary Registries Network (JPRN)
Recruitment status Recruiting
Study type Interventional
Phase 2
Countries Argentina;Japan;Austria;Japan;Belgium;Japan;Canada;Japan;China;Japan;Denmark;Japan;France;Japan;Germany;Japan;Israel;Japan;Itay;Japan;Republic of…
Conditions Patients with CSPH in compensated cirrhosis due to HBV, HCV, and NASH with or without T2DM
Interventions Treatment group 1, 2, 3: 685509 (maintenance dose) Treatment group 4: BI 685509 (maintenance dose) + Empagliflozin
Registration date Oct 14, 2022
Target size 5
Secondary IDs NCT05282121
Registry page jrct.niph.go.jp

At a glance

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