CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 479 enrolled
Drug / intervention
Andexanetbiological
Likely dose
Andexanet 400 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02329327
NCT02329327Phase 3Completed
CompareCT.gov

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

Alexion Pharmaceuticals, Inc.·interventional·Posted Dec 31, 2014·Updated Feb 16, 2022

In Brief

A Phase 3 clinical trial evaluating Andexanet for Bleeding. Completed, enrolled 479 participants across 87 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBleeding
CountriesBelgium, Canada, France, Germany, Japan, Netherlands, Spain, United Kingdom, United States
CollaboratorsPortola Pharmaceuticals, LLC (a wholly owned subsidiary of Alexion Pharmaceuticals), Population Health Research Institute

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 31, 2014
Enrollment StartApr 10, 2015
Primary CompletionSep 24, 2020
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 11.5 years ago

Interventions

Andexanetbiological

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.