andexanet alfa

💊Medication

Generic name

Andexanet Alfa

Brand names

Andexxa

Route

Intravenous

Type

Human Prescription Drug

Manufacturer

AstraZeneca Pharmaceuticals LP

Indications: 1 INDICATIONS AND USAGE ANDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. This indication is approved under accelerated approval based on the change from baseline in anti-FXa activit… (per FDA label)

• COMPLETED
  Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major BleedAstraZeneca · NCT05548777
• PHASE2COMPLETED
  A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian SubjectsPortola Pharmaceuticals · NCT03310021
• PHASE3COMPLETED
  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)Alexion Pharmaceuticals, Inc. · NCT02329327
• COMPLETED
  Retrospective Study on Characteristics and Outcomes in Hospitalised Patients Treated With OndexxyaAstraZeneca · NCT05898412
• PHASE3WITHDRAWN
  A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or ProcedureAstraZeneca · NCT05926349
• COMPLETED
  Andexanet Alfa: Non-interventional Study in Stroke Units in Germany (DE)University Hospital, Essen · NCT05127941

via ClinicalTrials.gov

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