clinical trial · NCT05045482
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
Hepatic ImpairmentCirrhosisCholestatic Liver DiseaseSaroglitazar Magnesium 1 mgSaroglitazar Magnesium 2 mg
brief summary
A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease
started
Oct 21, 2021
primary completion
Mar 31, 2026
completion
Mar 31, 2026
last updated
Feb 17, 2026
detailed description
Hepatic impairment study in subjects with cirrhosis secondary to cholestatic disease at a single and multiple once daily doses of Saroglitazar Magnesium needs to be conducted per discussion with FDA. Thus, an extension study has been added.
official title
A Phase 1, Open-Label Extension Groups Study in Subjects Having Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol