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NCT03310021 · ClinicalTrials.gov registry record · Phase 2
A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects
A Phase 2 study of Bleeding, sponsored by Portola Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 108
- Enrollment target
- 1
- Study location
NCT03310021 is a Phase 2 study of Bleeding that has completed, run by Portola Pharmaceuticals. The registered enrollment target is 108 participants, below the 1,480-participant average among 23 other Bleeding trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03310021, a Phase 2 study of Bleeding, has completed, sponsored by Portola Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 108 participants
- Enrollment target
- 1
- Study location
Study Summary
"This is a single-center, randomized, double-blind, and placebo-controlled trial designed to: 1) demonstrate the degree to which administered andexanet doses can reverse Factor Ten A (FXa)-inhibitor induced anticoagulation; and 2) evaluate the safety and PK/PD of andexanet in healthy Japanese subjects taking direct FXa inhibitors at therapeutic doses."
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Apixaban
- DRUG Rivaroxaban
- DRUG Edoxaban
- BIOLOGICAL Andexanet alfa
Study Locations (1)
California
- WCCT Global - Cypress
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2017-08-28 |
| Est. Completion | 2019-08-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03310021
The ClinicalTrials.gov registry entry for NCT03310021 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,480-participant average among 23 other Bleeding trials with a reported enrollment target (93% lower). The listed sponsor is Portola Pharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bleeding appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT03310021 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03310021 about?
NCT03310021 is a clinical study titled "A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects". "This is a single-center, randomized, double-blind, and placebo-controlled trial designed to: 1) demonstrate the degree to which administered andexanet doses can reverse Factor Ten A (FXa)-inhibitor induced anticoagulation; and 2) evaluate the safety and PK/PD of andexanet in healthy Japanese subjec...
What is the current status of trial NCT03310021?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2017-08-28. Estimated completion is 2019-08-13.
What conditions does trial NCT03310021 study?
This clinical trial studies the following conditions: Bleeding.
What interventions are being tested in trial NCT03310021?
The interventions under investigation include: Placebo (DRUG), Apixaban (DRUG), Rivaroxaban (DRUG), Edoxaban (DRUG), Andexanet alfa (BIOLOGICAL).
Who is sponsoring clinical trial NCT03310021?
This trial is sponsored by Portola Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03310021 being conducted?
This trial has 1 study location across California. 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
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.