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NCT03397888 · ClinicalTrials.gov registry record · Phase 1
The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist
A Phase 1 study of Hepatic Impairment, sponsored by Portola Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT03397888 is a Phase 1 study of Hepatic Impairment that has completed, run by Portola Pharmaceuticals. The registered enrollment target is 32 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (11% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03397888, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Portola Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
Single center, prospective open label PK and PD study of betrixaban in subjects with mild and moderate hepatic impairment vs healthy volunteers.
Conditions Studied
Interventions
- DRUG Betrixaban
Study Locations (1)
Florida
- Clinical Pharmacology of Miami - Hialeah
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-11-16 |
| Est. Completion | 2018-01-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03397888
The ClinicalTrials.gov registry entry for NCT03397888 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (11% lower). The listed sponsor is Portola Pharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which Betrixaban is the first listed.
NCT03397888 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT03397888 about?
NCT03397888 is a clinical study titled "The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist". Single center, prospective open label PK and PD study of betrixaban in subjects with mild and moderate hepatic impairment vs healthy volunteers.
What is the current status of trial NCT03397888?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2017-11-16. Estimated completion is 2018-01-16.
What conditions does trial NCT03397888 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT03397888?
The interventions under investigation include: Betrixaban (DRUG).
Who is sponsoring clinical trial NCT03397888?
This trial is sponsored by Portola Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03397888 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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