NCT02329327

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)

Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding (ANNEXA-4)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 479 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the hemostatic efficacy of andexanet alfa (andexanet) in participants receiving a factor Xa (FXa) inhibitor (apixaban, rivaroxaban, edoxaban, enoxaparin) who were experiencing an acute major bleed. The safety of andexanet was also studied.

Conditions

• Bleeding

Interventions

Type	Name	Description
BIOLOGICAL	Andexanet	There were 2 possible dosing regimens: Low dose = 400 milligram (mg) bolus plus 4 mg/minute continuous infusion for 120 minutes; High dose = 800 mg bolus plus 8 mg/minute continuous infusion for 120 minutes.

Timeline

• Start date: 2015-04-10
• Primary completion: 2020-09-24
• Completion: 2020-09-24
• First posted: 2014-12-31
• Last updated: 2022-02-16
• Results posted: 2022-02-16

Locations

87 sites across 9 countries: United States, Belgium, Canada, France, Germany, Japan, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study