14 completed, 2 terminated, 1 withdrawn. 7 Phase 2, 4 Phase 3, 3 Phase 1, 1 Phase 4.
By phase and status
Follow PRT064445: new trials by email Literature Review of PRT064445 trials Research Report on PRT064445
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 |
|---|
A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants
Andexanet alfa, Rivaroxaban, Apixaban - Healthy Participants | Phase 1 | Completed | AstraZeneca | 191 | 2026-01-19 | 2026-07-09 |
A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure
Andexanet alfa, Usual Care - Urgent Surgery | Phase 3 | Withdrawn | AstraZeneca | | 2024-08-02 | 2024-10-26 |
Retrospective Study on Characteristics and Outcomes in Hospitalised Patients Treated With Ondexxya
Andexanet alfa - Hemorrhage | | Completed | AstraZeneca | 217 | 2023-10-06 | 2026-04-17 |
Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed
Andexanet alfa, 4F-PCC - Anticoagulant-related Major Bleed | | Completed | AstraZeneca | 5480 | 2022-09-15 | 2023-11-28 |
Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery
andexanet alfa - Surgery | Phase 2 | Terminated | Alexion Pharmaceuticals, Inc. | 10 | 2021-06-27 | 2023-03-22 |
Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor
andexanet alfa, Usual Care - Acute Intracranial Hemorrhage | Phase 4 | Completed | Alexion Pharmaceuticals, Inc. | 530 | 2019-06-06 | 2024-07-03 |
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 |
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 Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)
Andexanet - Bleeding | Phase 3 | Completed | Alexion Pharmaceuticals, Inc. | 479 | 2015-04-10 | 2022-02-16 |
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 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 |
Conditions studied
Hemorrhage (7) · Thrombosis (2)
Sponsors
Portola Pharmaceuticals (10) · AstraZeneca (4) · Alexion Pharmaceuticals, Inc. (3)
Countries
United States (12) · Germany (4) · France (3) · Netherlands (3) · United Kingdom (3) · Austria (2) · Belgium (2) · Canada (2) · Israel (2) · Japan (2) · Spain (2) · Czechia (1) · Denmark (1) · Finland (1) · Greece (1)
Top investigators
Vandana Mathur, M.D. (2)
Results publications
PMID 26559317, PMID 32092140, PMID 38264861, PMID 27573206, PMID 28009495, PMID 29296829, PMID 30730782, PMID 33966491, PMID 34645283, PMID 35710578, PMID 36802876, PMID 37314165, PMID 37753225, PMID 38749032, PMID 39002730, PMID 39167819, PMID 39524040, PMID 40289797, PMID 42093656
NIH funding
2018 (1), 2025 (1)