20 completed, 2 terminated, 2 withdrawn, 1 recruiting. 12 Phase 2, 9 Phase 1, 4 Phase 3, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 12 | Completed 10, Terminated 1, Withdrawn 1 |
| Phase 1 | 9 | Completed 8, Terminated 1 |
| Phase 3 | 4 | Completed 3, Withdrawn 1 |
| Not applicable | 1 | Recruiting 1 |
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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 |
|---|---|---|---|---|---|---|
| CELTIC-1: A Phase 2B Study of Cerdulatinib in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) Cerdulatinib - Peripheral T-Cell Lymphoma (PTCL NOS), Nodal Lymphomas of T Follicular Helper (TFH) | Phase 2 / Phase 3 | Withdrawn | Portola Pharmaceuticals | 2019-11-15 | 2023-02-21 | |
| Computerized Decision Support for Prevention of VTE in Hospitalized Medical Patients Across the Continuum of Care (DC-eALERT) Electronic alert - Venous Thromboembolism | Not applicable | Recruiting | Brigham and Women's Hospital | 400 | 2019-02-01 | 2026-09-29 |
| BRAVO - Betrixaban Registry Using Real Time Observations in Acute Medical Illness to Assess Venous Thrombosis and Bleeding Outcomes Venous Thromboses | Withdrawn | Portola Pharmaceuticals | 2018-09-01 | 2023-02-21 | ||
| 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 Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects Andexanet alfa, Apixaban, Rivaroxaban - Bleeding | Phase 2 | Completed | Portola Pharmaceuticals | 108 | 2017-08-28 | 2023-02-24 |
| A Healthy Volunteer PK/PD, Safety and Tolerability Study of Second Generation Andexanet Alfa Andexanet alfa (Gen 1 Process 2), Apixaban 5 MG, Rivaroxaban 20 MG - Bleeding | Phase 1 | Completed | Portola Pharmaceuticals | 153 | 2017-02-26 | 2023-08-08 |
| Safety of Oral Anticoagulants Registry mgt of bleeding concerns/complications of oral anticoagulants - Blood Coagulation | Unknown | Hospital Quality Foundation | 1500 | 2016-08-01 | 2018-05-22 | |
| 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 |
| A Study in Older Subject to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Rivaroxaban Andexanet, Placebo - Bleeding | Phase 3 | Completed | Portola Pharmaceuticals | 80 | 2014-05-01 | 2023-02-10 |
| A Study in Older Subjects to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Apixaban Andexanet, Placebo - Bleeding | Phase 3 | Completed | Portola Pharmaceuticals | 68 | 2014-03-01 | 2023-08-08 |
| Phase 1/2a Dose Escalation Study in Participants With CLL, SLL, or NHL Cerdulatinib, Rituximab - Follicular Lymphoma (FL/Indolent NHL), Aggressive NHL (a NHL) | Phase 1 / Phase 2 | Completed | Alexion Pharmaceuticals, Inc. | 260 | 2013-08-30 | 2022-04-05 |
| Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 3 of 4) PRT064445/Enoxaparin, Placebo/Enoxaparin, Placebo - Healthy Volunteers | Phase 2 | Completed | Portola Pharmaceuticals | 27 | 2012-12-01 | 2023-02-22 |
| Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 2 of 4) PRT064445/Rivaroxaban, Placebo/Rivaroxaban, Placebo - Healthy Volunteers | Phase 2 | Completed | Portola Pharmaceuticals | 48 | 2012-12-01 | 2023-02-22 |
| Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 1 of 4) PRT064445/Apixaban, Placebo/Apixaban, Placebo - Healthy Volunteers | Phase 2 | Completed | Portola Pharmaceuticals | 54 | 2012-12-01 | 2023-08-07 |
| Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 4 of 4) PRT064445/Edoxaban, Placebo/Edoxaban, Placebo - Healthy Volunteers | Phase 2 | Completed | Portola Pharmaceuticals | 28 | 2012-12-01 | 2023-02-21 |
| Single Ascending Dose Study of PRT064445, a Factor Xa (fXa) Inhibitor Antidote PRT064445, Placebo - Healthy | Phase 1 | Completed | Portola Pharmaceuticals | 32 | 2012-06-01 | 2023-08-04 |
| 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 |
| Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment Elinogrel - Renal Impairment | Phase 1 | Terminated | Portola Pharmaceuticals | 44 | 2009-09-01 | 2023-08-04 |
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Hemorrhage (6) · Atrial Fibrillation (2) · Renal Insufficiency (2) · Venous Thromboembolism (2) · Atrial Flutter (1) · Bronchiolitis Obliterans Syndrome (1) · Leukemia (1) · Leukemia, Lymphocytic, Chronic, B-Cell (1) · Leukemia, T-Cell (1) · Lymphoma, B-Cell (1) · Lymphoma, Follicular (1) · Lymphoma, Non-Hodgkin (1) · Lymphoma, T-Cell (1) · Lymphoma, T-Cell, Cutaneous (1) · Lymphoma, T-Cell, Peripheral (1)
PRT064445 (10) · betrixaban (9) · Enoxaparin (3) · Rivaroxaban (3) · apixaban (3) · edoxaban (3) · 4-(cyclopropylamino)-2-((4-(4-(ethylsulfonyl)piperazin-1-yl)phenyl)amino)pyrimidine-5-carboxamide (2) · elinogrel (2) · Acenocoumarol (1) · Amiodarone (1) · Clopidogrel (1) · Injections, Intravenous (1) · Rituximab (1) · Warfarin (1) · enoxaparin sodium (1)
United States (17) · Canada (4) · Germany (3) · Austria (2) · Poland (2) · Argentina (1) · Australia (1) · Belgium (1) · Brazil (1) · Bulgaria (1) · Chile (1) · Croatia (1) · Czechia (1) · Denmark (1) · Estonia (1)
Vandana Mathur, M.D. (2) · Charles V Pollack, MD (1) · Gregory Piazza, MD, MS (1) · Matthew W McClure, MD (1) · Michael Ezekowitz, MD, PhD, (1) · Paul Dorian, MD (1) · Rafael Diaz, MD (1) · Robert C Welsh, MD (1) · Robert Harrington, MD (1) · Stefan H. Hohnloser, MD (1) · Stuart Connolly, MD, FRCP (1) · Sunil V Rao, MD (1)
PMID 26559317, PMID 32092140, PMID 22619259, PMID 22647518, PMID 24576517, PMID 27232649, PMID 27881569, PMID 28617144, PMID 28625365, PMID 28698258, PMID 28762617, PMID 28840662, PMID 28905172, PMID 29188425, PMID 29212126, PMID 29296829, PMID 30252149, PMID 30333224, PMID 30419597, PMID 30778649, PMID 31215264, PMID 31249989, PMID 32657973, PMID 36566304
2008 (1)