Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-03-05 @ 7:58 PM
Study NCT ID:
NCT04469920
Status:
COMPLETED
Last Update Posted:
2024-09-20
First Post:
2020-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function
Sponsor:
Zydus Therapeutics Inc.
Organization:
Study Overview
Official Title:
Evaluation of Pharmacokinetics and Safety of Saroglitazar Magnesium in Participants with Normal Hepatic Function and with Hepatic Impairment, Cholestatic Liver Disease, NASH with Advanced Fibrosis
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be a Phase 1, Open-label Study of Participants with Hepatic Impairment, Cholestatic Liver Disease, and NASH with Advanced Fibrosis and Normal Hepatic Function
Detailed Description:
Male and female participants 18-80 years of age (inclusive) with normal hepatic function or hepatic impairment/disease who meet all of the inclusion and none of the exclusion criteria. Subjects with hepatic impairment will be enrolled based upon the Child-Pugh-Turcotte (CPT) classification system for mild hepatic impairment (Group 1 CPT Class A without PHT; Group 2 CPT Class A with PHT), moderate hepatic impairment (Group 3 Decompensated CPT Class B), or severe hepatic impairment (Group 4 Decompensated CPT Class C). Group 5 will include subjects with cholestatic liver disease and Group 6 will include subjects with non-cirrhotic advanced fibrosis secondary to NASH (non-alcoholic steatohepatitis). The control group (Group 7) will consist of demographic matched subjects with normal hepatic function.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: