Trial Profile

A Phase 1, Open-Label Extension Groups Study in Subjects Having Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

Status: Recruiting

Phase of Trial: Phase I

Latest Information Update: 05 Sep 2025

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At a glance

Drugs Saroglitazar (Primary)
Indications Liver cirrhosis; Liver disorders
Focus Adverse reactions; Pharmacokinetics
Sponsors Zydus Cadila

Most Recent Events

15 Aug 2025 Planned End Date changed from 30 Jun 2024 to 31 Dec 2025.
15 Aug 2025 Planned primary completion date changed from 30 Jun 2024 to 31 Dec 2025.
04 Mar 2025 Planned number of patients changed from 24 to 30.

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