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

Phase 3

Completed

• Conditions: Acute Major Bleeding

• Registration Number: NL-OMON45055
• Lead Sponsor: PORTOLA PHARMACEUTICALS, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

1) Either the patient or his or her medical proxy (or legally acceptable
designee) has been adequately informed of the nature and risks of the study and has given written
informed consent prior to Screening;
2) The patient must be at least 18 years old at the time of Screening;
3) The patient must have an acute overt major bleeding episode requiring urgent reversal of
anticoagulation; Acute major bleeding requiring urgent reversal of anticoagulation is defined by at
least ONE of the following:
- Acute overt bleeding that is potentially life-threatening, e.g., with signs or symptoms of
haemodynamic compromise, such as severe
hypotension, poor skin perfusion, mental confusion, low urine output that cannot be otherwise
explained;
- Acute overt bleeding associated with a fall in haemoglobin level by * 2 g/dL, OR a Hgb * 8 g/dL
if no baseline Hgb is available;
- Acute bleeding in a critical area or organ, such as, intra-spinal, pericardial or intracranial.
4) The patient, for whom the bleeding is intracranial or intraspinal must have undergone a CT or
MRI scan demonstrating the bleeding.
5) The patient received or is believed to have received one of the following within 18 hours prior
to andexanet administration: apixaban, rivaroxaban, edoxaban or enoxaparin (dose of enoxaparin
*1mg/kg/d).
6) For patients with ICH, there must be a reasonable expectation that andexanet treatment will
commence within 2 hours of the baseline
imaging evaluation.

Exclusion Criteria

1) The patient is scheduled to undergo surgery in less than 12 hours
with the exception of minimally invasive surgery/procedures (e.g.,
endoscopy, bronchoscopy, central lines, Burr holes);
2) A patient with ICH has any of the following:
* Glasgow coma score < 7
* Estimated intracerebral haematoma volume >60 cc as assessed by the
CT or MRI.
3) Patients with visible, musculoskeletal, or intra-articular bleeding as
the qualifying bleed.
4) The patient has an expected survival of less than 1 month;
5) The patient has a recent history (within 2 weeks) of a diagnosed
thrombotic event (TE) as follows: venous thromboembolism (VTE; e.g.,
deep venous thrombosis, pulmonary embolism, cerebral venous
thrombosis), myocardial infarction, disseminated intravascular
coagulation (DIC), cerebral vascular accident, transient ischemic attack,
unstable angina pectoris hospitalization, or severe peripheral vascular
disease within 2 weeks prior to Screening;
6) The patient has severe sepsis or septic shock at the time of Screening;
7) The patient is pregnant or a lactating female;
8) The patient has received any of the following drugs or blood products
within 7 days or Screening:
* Vitamin K antagonist (VKA) (e.g., warfarin);
* Dabigatran;
* Prothrombin Complex Concentrate products (PCC, e.g., Kcentra®) or
recombinant factor VIIa (rfVIIa) (e.g., NovoSeven®);
* Whole blood, plasma fractions
Note: Administration of platelets or packed red blood cells (PRBCs) is not
an exclusion criterion;
9) The patient was treated with an investigational drug <30 days prior
to Screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified