Adults 18 to 75, any sex, with Bleeding. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent Change in Anti-Fxa Activity From Baseline to the End of Infusion (EOI) Nadir.Primary· Baseline to the end of infusion (EOI) nadir, approximately 2.5 hours
The primary efficacy endpoint is the percent change in the anti-FXa activity from baseline to the end of infusion (EOI) nadir.
Group
Value
95% CI
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet
-94.50
-96.00 – -90.00
Cohort 1 Apixaban 5 mg BID/Placebo
-29.00
-32.00 – -18.00
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet
-98.00
-99.00 – -97.00
Cohort 2 Rivaroxaban 15 mg BID/Placebo
-37.00
-53.00 – -34.00
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet
-81.00
-89.00 – -51.00
Cohort 3 Edooxaban 60 mg QD/Placebo
-47.50
-62.00 – -34.00
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet
-75.50
-82.00 – -45.00
Cohort 4 Edooxaban 60 mg QD/Placebo
-37.00
-46.00 – -16.00
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet
-93.00
-94.00 – -91.00
Cohort 5 Apixaban 5 mg BID/Placebo
-34.00
-53.00 – -24.00
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet
-97.00
-98.00 – -96.00
Cohort 6 Apixaban 10 mg BID/Placebo
-31.00
-35.00 – -30.00
Percent Change in Anti-Fxa Activity From Baseline to the End of Bolus (EOB) Nadir.Secondary· Baseline to the end of bolus (EOB) nadir, approximately 2.5 hours
The percent change from baseline in anti-FXa activity at its end of bolus (EOB) nadir.
Group
Value
95% CI
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet
-94.50
-95.00 – -92.00
Cohort 1 Apixaban 5 mg BID/Placebo
-14.00
-15.00 – -12.00
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet
-97.50
-98.00 – -96.00
Cohort 2 Rivaroxaban 15 mg BID/Placebo
-18.00
-29.00 – -1.00
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet
-65.50
-87.00 – -8.00
Cohort 3 Edooxaban 60 mg QD/Placebo
-16.00
-46.00 – -13.00
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet
-22.50
-78.00 – 0.00
Cohort 4 Edooxaban 60 mg QD/Placebo
-15.00
-19.00 – 7.00
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet
-94.00
-94.00 – -92.00
Cohort 5 Apixaban 5 mg BID/Placebo
-10.00
-21.00 – -7.00
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet
-96.00
-97.00 – -95.00
Cohort 6 Apixaban 10 mg BID/Placebo
-18.00
-21.00 – -14.00
Percent Change in Free Fxa Inhibitor Concentration From Baseline to the End of Bolus (EOB) Nadir.Secondary· Baseline to the end of bolus (EOB) nadir, approximately 2.5 hours
The percent change from baseline in free FXa inhibitors concentration (ng/mL) at its EOB nadir.
Group
Value
95% CI
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet
-93.00
-94.70 – -90.38
Cohort 1 Apixaban 5 mg BID/Placebo
-11.94
-18.42 – -1.71
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet
-97.72
-97.97 – -95.70
Cohort 2 Rivaroxaban 15 mg BID/Placebo
-28.57
-47.06 – -1.06
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet
-78.20
-86.17 – -59.17
Cohort 3 Edooxaban 60 mg QD/Placebo
-17.60
-27.95 – -10.15
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet
-56.05
-77.92 – -40.69
Cohort 4 Edooxaban 60 mg QD/Placebo
-2.49
-28.57 – 12.48
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet
-94.45
-96.56 – -93.04
Cohort 5 Apixaban 5 mg BID/Placebo
5.80
-8.56 – 36.52
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet
-93.57
-97.30 – -90.08
Cohort 6 Apixaban 10 mg BID/Placebo
-12.94
-24.34 – -10.94
Percent Change in Free Fxa Inhibitor Concentration From Baseline to the End of Infusion (EOI) Nadir.Secondary· Baseline to the end of infusion (EOI) nadir, approximately 2.5 hours
The percent change from baseline in free FXa inhibitors concentration (ng/mL) at its EOI nadir.
Group
Value
95% CI
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet
-92.940
-94.610 – -90.400
Cohort 1 Apixaban 5 mg BID/Placebo
-33.550
-37.780 – -28.130
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet
-98.650
-99.060 – -97.610
Cohort 2 Rivaroxaban 15 mg BID/Placebo
-39.390
-70.670 – -28.720
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet
-85.005
-93.140 – -68.740
Cohort 3 Edooxaban 60 mg QD/Placebo
-48.710
-49.790 – -38.980
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet
-81.040
-89.300 – -67.660
Cohort 4 Edooxaban 60 mg QD/Placebo
-42.755
-53.330 – -25.890
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet
-93.495
-96.180 – -91.240
Cohort 5 Apixaban 5 mg BID/Placebo
-31.830
-47.460 – -20.360
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet
-96.65
-97.62 – -94.80
Cohort 6 Apixaban 10 mg BID/Placebo
-29.02
-32.81 – -20.22
Change in Thrombin Generation From Baseline to the End of Bolus (EOB) Nadir.Secondary· Baseline to the end of bolus (EOB) nadir, approximately 2.5 hours
The change in thrombin generation from baseline to its EOB peak.
Group
Value
95% CI
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet
1145.03
708.92 – 1538.44
Cohort 1 Apixaban 5 mg BID/Placebo
179.94
161.09 – 234.44
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet
1337.28
1155.95 – 1632.28
Cohort 2 Rivaroxaban 15 mg BID/Placebo
209.99
57.26 – 386.49
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet
758.92
560.66 – 1494.51
Cohort 3 Edooxaban 60 mg QD/Placebo
215.71
-15.75 – 319.23
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet
815.07
603.90 – 949.73
Cohort 4 Edooxaban 60 mg QD/Placebo
48.59
22.87 – 165.84
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet
1244.30
1106.36 – 1714.52
Cohort 5 Apixaban 5 mg BID/Placebo
103.13
-22.26 – 142.33
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet
1177.47
1081.47 – 1564.10
Cohort 6 Apixaban 10 mg BID/Placebo
0.16
-106.20 – 92.65
Change in Thrombin Generation From Baseline to the End of Infusion (EOI) Nadir.Secondary· Baseline to the end of infusion (EOI) nadir, approximately 2.5 hours
The change in thrombin generation from baseline to its EOI peak.
Group
Value
95% CI
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet
1000.630
695.120 – 1519.850
Cohort 1 Apixaban 5 mg BID/Placebo
171.220
157.740 – 189.720
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet
1329.580
1161.360 – 1679.680
Cohort 2 Rivaroxaban 15 mg BID/Placebo
207.590
126.910 – 287.490
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet
804.405
692.880 – 1560.300
Cohort 3 Edooxaban 60 mg QD/Placebo
347.535
107.360 – 482.840
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet
910.935
775.950 – 1108.160
Cohort 4 Edooxaban 60 mg QD/Placebo
236.610
126.010 – 295.710
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet
1130.575
1022.120 – 1460.710
Cohort 5 Apixaban 5 mg BID/Placebo
118.130
108.660 – 163.040
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet
1119.41
969.95 – 1567.02
Cohort 6 Apixaban 10 mg BID/Placebo
108.67
-67.28 – 150.99
Adverse events — posted to ClinicalTrials.gov
Time frame: Study day 1 to 39.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
"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."
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT07312851 — A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Parti
· Phase 1
· recruiting
NCT05926349 — A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure
· Phase 3
· withdrawn
NCT05898412 — Retrospective Study on Characteristics and Outcomes in Hospitalised Patients Treated With Ondexxya
· completed
NCT05548777 — Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed
· completed
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Currently open trials in the same condition.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Portola Pharmaceuticals
Last refreshed: 24 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03310021.