Trial Results

Protocol
Available Languages: English
Statistical Analysis Plan
Available Languages: English

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)

Study Identifier:
14-505
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Biological: Andexanet
Date
Apr 2015 - Sep 2020
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Biological: Andexanet
Date
Apr 2015 - Sep 2020
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information

Protocol 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.

Trial Locations

Location
Status
Location
Clinical Study Site
Long Beach, California, United States
Status
N/A
Location
Clinical Study Site
Los Angeles, California, United States
Status
N/A
Location
Clinical Study Site
Orange, California, United States
Status
N/A
Location
Clinical Study Site
Fort Lauderdale, Florida, United States
Status
N/A
Location
Clinical Study Site
Jacksonville, Florida, United States
Status
N/A
Location
Clinical Study Site
Sarasota, Florida, United States
Status
N/A