8 completed, 2 terminated, 1 withdrawn. 5 Phase 1, 4 Phase 2, 1 Not applicable, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 5 | Completed 4, Terminated 1 |
| Phase 2 | 4 | Completed 3, Terminated 1 |
| Not applicable | 1 | Withdrawn 1 |
| Phase 3 | 1 | Completed 1 |
Follow betrixaban: new trials by email Literature Review of betrixaban trials Research Report on betrixaban
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF LAmbre PlusTM Left Atrial Appendage Closure System, Market approved oral anticoagulation (OAC), such as warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixiban (Eliquis), edoxaban (Savaysa), or betrixaban (Bevyxxa) - Atrial Fibrillation, Left Atrial Appendage Thrombosis | Not applicable | Withdrawn | Brian O'Neill MD | 2024-06-01 | 2025-11-04 | |
| Study Evaluating Betrixaban in Pediatric Participants Betrixaban - VTE Prophylaxis | Phase 1 | Terminated | Alexion Pharmaceuticals, Inc. | 21 | 2018-07-13 | 2024-01-12 |
| The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist Betrixaban - Hepatic Impairment | Phase 1 | Completed | Portola Pharmaceuticals | 32 | 2017-11-16 | 2023-02-21 |
| A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations Betrixaban - Healthy | Phase 1 | Completed | Portola Pharmaceuticals | 52 | 2015-09-01 | 2023-08-08 |
| A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing Andexanet alfa (bolus), Betrixaban 80 mg PO QD, Andexanet alfa (infusion IV) - Bleeding | Phase 2 | Terminated | Portola Pharmaceuticals | 18 | 2015-08-06 | 2023-08-08 |
| Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study) Betrixaban, Enoxaparin - Venous Thromboembolism (VTE) | Phase 3 | Completed | Portola Pharmaceuticals | 7513 | 2012-03-01 | 2023-08-07 |
| Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter Amiodarone, Betrixaban 60 mg, Betrixaban 90 mg - Atrial Fibrillation, Atrial Flutter | Phase 2 | Completed | Portola Pharmaceuticals | 189 | 2010-09-01 | 2023-08-07 |
| A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment Betrixaban - Renal Impairment | Phase 1 | Completed | Portola Pharmaceuticals | 32 | 2009-07-31 | 2023-08-22 |
| Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin betrixaban, Warfarin - Atrial Fibrillation | Phase 2 | Completed | Portola Pharmaceuticals | 508 | 2008-10-01 | 2023-08-07 |
| A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers Betrixaban - Healthy Subjects | Phase 1 | Completed | Portola Pharmaceuticals | 8 | 2007-09-01 | 2023-08-08 |
| Factor Xa Inhibitor, PRT054021, Against Enoxaparin for the Prevention of Venous Thromboembolic Events (EXPERT) Betrixaban, Enoxaparin - Thromboembolism | Phase 2 | Completed | Portola Pharmaceuticals | 215 | 2006-05-01 | 2023-08-07 |
Atrial Fibrillation (3) · Thromboembolism (2) · Atrial Flutter (1) · Hemorrhage (1) · Renal Insufficiency (1) · Thrombosis (1) · Venous Thromboembolism (1)
Portola Pharmaceuticals (9) · Alexion Pharmaceuticals, Inc. (1) · Brian O'Neill MD (1)
United States (6) · Canada (3) · Germany (2) · Russia (2) · Ukraine (2) · United Kingdom (2) · Argentina (1) · Australia (1) · Austria (1) · Belgium (1) · Brazil (1) · Bulgaria (1) · Chile (1) · Croatia (1) · Czechia (1)
Brian O'Neill, MD (1) · Michael Ezekowitz, MD, PhD, (1) · Paul Dorian, MD (1) · Rafael Diaz, MD (1) · Stefan H. Hohnloser, MD (1) · Stuart Connolly, MD, FRCP (1)
PMID 24576517, PMID 27232649, PMID 27881569, PMID 28617144, PMID 28625365, PMID 28698258, PMID 28762617, PMID 28840662, PMID 28905172, PMID 29188425, PMID 29212126, PMID 30252149, PMID 30419597, PMID 30778649, PMID 31215264, PMID 31249989, PMID 32657973, PMID 36566304
2018 (1)