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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: Completed Phase 1 study of Hepatic Impairment, sponsored by Portola Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Plasma half-life (t1/2), distribution half-life and terminal half-life.
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 |
What the finished NCT03397888 record still lists
NCT03397888 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (11% lower).
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 a single indexed study location in 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
Similar trials for Hepatic Impairment
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 NCT03397888's enrollment target sits among peer trials
32 13th of 48 higher than 30 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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