Study of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on direct oral anticoagulant (DOAC) therapy with factor Xa inhibitor.

Octapharma AG, Octapharma AG23 sites in 6 countries90 target enrollmentStarted: August 22, 2024Last updated: April 25, 2025

Trial Snapshot

Phase: Phase 3
Status: Recruiting
Sponsor
Enrollment: 90
Locations: 23
Primary Endpoint: The proportion of patients in whom OCTAPLEX demonstrates haemostatic effectiveness, i.e., binary outcome of effective (rating of excellent or good) or non-effective (rating of poor/none) in management of major bleeding events.

Study Overview Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

To demonstrate superior haemostatic effectiveness of OCTAPLEX dosed at 50 IU/Kg body weight vs. 15 IU/Kg body weight for emergency reversal of the anticoagulant effect of DOACs in patients with major bleeding associated with factor Xa inhibition.

Eligibility Criteria

Ages: 18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•Patients on oral factor Xa inhibitor therapy and with known or suspected baseline anti-factor Xa activity of at least 100 ng/mL: Patients who received or who are believed by the investigator to have received a dose of oral factor Xa inhibitor and who have a baseline antifactor Xa activity of at least 100 ng/mL according to the locally available test (e.g., chromogenic assay) performed outside of the study as part of standard of care OR -Patients who received or who are believed by the investigator to have received their latest dose of oral factor Xa inhibitor (e.g., rivaroxaban ≥ 10 mg, apixaban ≥2.5 mg, edoxaban ≥30 mg) ≤8 hours prior to enrolment OR -Patients who received or who are believed by the investigator to have received their latest dose of oral factor Xa inhibitor (e.g., rivaroxaban ≥ 10 mg, apixaban ≥2.5 mg, edoxaban ≥30 mg) >8 hours prior to enrolment or at an unknown time, but for whom the investigator suspects a baseline anti-factor Xa activity of at least 100 ng/mL and assesses that the administration of OCTAPLEX is clinically indicated
•Aged ≥18 years
•Patients who have given written informed consent or for whom written informed consent has been obtained from the patient's legally authorised representative on their behalf - Wherever possible, prospective written informed consent will be obtained before enrolment from the patient or, if they are incapable of providing it, from their legally authorised representative;- If prospective written informed consent is not possible, deferred consent procedures will be permitted outside the US if approved by the local ethics committee or otherwise permitted under local regulations;- When deferred consent procedures are used outside the US, written informed consent should be obtained from the patient as soon as they recover the capacity to provide it, or otherwise from their legally authorised representative
•Patients who have acute major bleeding defined as follows: - Bleeding that is life-threatening or uncontrolled, e.g., with signs or symptoms of haemodynamic compromise, such as severe hypotension, poor skin perfusion, or low cardiac output that cannot be otherwise explained OR - Symptomatic bleeding in critical organs (intracranial, intraspinal, intraocular, gastrointestinal ,retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome) OR - - Acute overt bleeding associated with a fall in haemoglobin (Hgb) level of ≥2 g/dL, OR a Hgb level ≤8 g/dL if no baseline Hgb level is available, OR in the opinion of the investigator that the patient's Hgb level will fall to ≤8 g/dL with resuscitation

Exclusion Criteria

•Patients with ‘Do not resuscitate’ (DNR) orders
•Patients who received ticlopidine within 14 days, prasugrel within 7 days, clopidogrel within 5 days, ticagrelor within 5 days , dipyridamole within 1 day or cangrelor within 1 hour preceding the bleeding event
•Patients on enoxaparin therapy for thromboembolic prophylaxis
•A score of less than 7 on the Glasgow Coma Scale in non-intubated patients or an estimated intracerebral haematoma volume of more than 60 mL (Patients intubated or sedated at the time of screening may be enrolled if intubation or sedation were done for non-neurologic reasons)
•Patients with expected survival of less than 24 hours, in the opinion of the investigator (in collaboration with other medical experts as appropriate per usual local practice)
•Patients scheduled to undergo surgery in less than 12 hours, with the exception of minor/surgeries and invasive procedures which are allowed for diagnostic or therapeutic reasons or if intended to address a second (non-index) bleeding event
•Patients who are pregnant or breastfeeding at the time of enrolment
•Patients previously enrolled in this study
•Patients participating in another interventional clinical treatment study currently or during the past 1 month prior to study inclusion
•Patients with acute trauma for which reversal of DOAC therapy with factor Xa inhibitor alone would not be expected to control the bleeding event
•Hgb decrease without accompanying evidence of source of bleeding
•Acute coronary syndrome, ischaemic stroke or venous thromboembolism (VTE) within the preceding 3 months
•Patients with a history, within the last 3 months, of disseminated intravascular coagulation (DIC) or hyperfibrinolysis
•Patients with a known congenital bleeding disorder
•Known inhibitors to coagulation factors II, VII, IX, or X; heparininduced, type II thrombocytopenia; or immunoglobulin A (IgA) deficiency with known antibodies against IgA
•Known hypersensitivity to plasma-derived products or heparin
•Patients who received haemostatic agents, including plasma, platelets, PCC, activated PCC (aPCC), recombinant factor VIIa, or recombinant factor Xa inactivated-zhzo (andexanet alfa), for the current bleeding event prior to enrolment (antifibrinolytic drugs and local haemostatic agents are allowed)

Outcomes

Primary Outcomes

The proportion of patients in whom OCTAPLEX demonstrates haemostatic effectiveness, i.e., binary outcome of effective (rating of excellent or good) or non-effective (rating of poor/none) in management of major bleeding events.

Secondary Outcomes

Change in endogenous thrombin potential (ETP) as measured by thrombin generation assay (TGA) from baseline to 1 hour after OCTAPLEX administration
30-day event rate of thromboembolic events (TEEs) and all-cause mortality
Occurrence of adverse events (AEs) during a 48-hours follow up period after OCTAPLEX administration
Vital signs and laboratory parameters during a 48-hours follow up period after OCTAPLEX administration

Investigators

Sponsor

Octapharma AG, Octapharma AG

Sponsor Class

Pharmaceutical company, Pharmaceutical company

Responsible Party

Principal Investigator

Assoc. Prof., MD, MBA, VP, Clinical R&D Haematology

Scientific

Octapharma AG

Study Sites (23)

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