A study to confirm that andexanet alfa helps to stop severe/ life threatening bleeding in patients, taking a type of anticoagulants called Factor Xa inhibitors.
- Conditions
- ncontrolled bleeding in patients who have taken either a direct factor Xa inhibitor (novel oral anticoagulants) or an indirect factor Xa inhibitor (low molecular weight heparins).MedDRA version: 20.0Level: LLTClassification code 10075279Term: Anticoagulant reversal therapySystem Organ Class: 100000004865Therapeutic area: Not possible to specify
- Registration Number
- EUCTR2015-001785-26-BE
- Lead Sponsor
- Portola Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 350
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 must have undergone a head CT or MRI scan demonstrating the intracranial bleeding. Note: Patients with bleeding at non-intracranial locations do not require a head CT or MRI;
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 245
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.
10) Planned administration of PCC, fresh frozen plasma (FFP), or rfVIIa from Screening until within 12 hours after the end of the andexanet infusion.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method