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Clinical Trial Summary

A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05045482
Study type Interventional
Source Zydus Therapeutics Inc.
Contact Farheen Shaikh
Phone +1 6094534751
Email fshaikh@zydustherapeutics.com
Status Recruiting
Phase Phase 1
Start date October 21, 2021
Completion date July 2024

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