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NCT04469920 · ClinicalTrials.gov registry record · Phase 1
Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function
A Phase 1 study of Hepatic Impairment, sponsored by Zydus Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
- 2
- Study locations
NCT04469920 is a Phase 1 study of Hepatic Impairment that has completed, run by Zydus Therapeutics. The registered enrollment target is 98 participants, above the 34-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (188% higher). The trial reports 2 study locations across 2 states.
The verdict
NCT04469920, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Zydus Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
- 2
- Study locations
Study 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
Conditions Studied
Interventions
- DRUG Saroglitazar Magnesium 2 mg
- DRUG Saroglitazar Magnesium 4 mg
Study Locations (2)
Indiana
- Indiana University School of Medicine - Indianapolis
Texas
- American Research Corporation at Texas Liver Institute - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2020-07-16 |
| Est. Completion | 2022-03-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04469920
The ClinicalTrials.gov registry entry for NCT04469920 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 34-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (188% higher). The listed sponsor is Zydus Therapeutics, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 2 interventions - of which Saroglitazar Magnesium 2 mg is the first listed.
NCT04469920 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Indiana, Texas.
Frequently Asked Questions
What is clinical trial NCT04469920 about?
NCT04469920 is a clinical study titled "Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function". 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
What is the current status of trial NCT04469920?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2020-07-16. Estimated completion is 2022-03-21.
What conditions does trial NCT04469920 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT04469920?
The interventions under investigation include: Saroglitazar Magnesium 2 mg (DRUG), Saroglitazar Magnesium 4 mg (DRUG).
Who is sponsoring clinical trial NCT04469920?
This trial is sponsored by Zydus Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04469920 being conducted?
This trial has 2 study locations across Indiana, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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