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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: Completed Phase 2 study of Bleeding, sponsored by Portola Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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."
Primary Outcome
The primary efficacy endpoint is the percent change in the anti-FXa activity from baseline to the end of infusion (EOI) nadir.
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 |
What the finished NCT03310021 record still lists
NCT03310021 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 1,480-participant average among 23 other Bleeding trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Bleeding
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 NCT03310021's enrollment target sits among peer trials
108 18th of 23 higher than 6 of 23 other Bleeding trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bleeding 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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