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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: Completed Phase 1 study of Hepatic Impairment, sponsored by Zydus Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The area under the plasma concentration versus time curve from zero to infinity will be calculated by adding Ct/Kel to AUCt, where Ct is the last quantifiable concentration and Kel is the elimination rate constant.
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 |
What the finished NCT04469920 record still lists
NCT04469920 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, above the 34-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (188% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04469920's enrollment target sits among peer trials
98 3rd of 48 higher than 46 of 48 other Hepatic Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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