Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor
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| ClinicalTrials.gov Identifier: NCT04867837 |
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Recruitment Status :
Recruiting
First Posted : April 30, 2021
Last Update Posted : May 9, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Major Bleeding | Drug: Octaplex | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 260 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Masking Description: | Blinded |
| Primary Purpose: | Treatment |
| Official Title: | Study of Four-factor Prothrombin Complex Concentrate, OCTAPLEX, in Patients With Acute Major Bleeding on Direct Oral Anticoagulant (DOAC) Therapy With Factor Xa Inhibitor |
| Actual Study Start Date : | September 1, 2021 |
| Estimated Primary Completion Date : | December 2024 |
| Estimated Study Completion Date : | December 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Octaplex Low-dose
Participants to receive 1 Octaplex infusion intravenously
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Drug: Octaplex
Four-factor prothrombin complex concentrate (4F-PCC) |
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Experimental: Octaplex High-dose
Participants to receive 1 Octaplex infusion intravenously
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Drug: Octaplex
Four-factor prothrombin complex concentrate (4F-PCC) |
- Hemostatic efficacy [ Time Frame: Within 24 hours after the start of initial management ]Binary outcome of effective (rating of excellent or good) or non-effective (rating of poor/none) in management of major bleeding events as assessed by the Independent Data Monitoring and Endpoint Adjudication Committee (IDMEAC) according to predefined criteria
- Change in endogenous thrombin potential (ETP) [ Time Frame: From baseline to 1 hour after administration of drug ]Change in ETP as measured by thrombin generation assay
- All-cause TEEs and All-cause Mortality [ Time Frame: 30 days ]30-day event rate of thromboembolic events (TEEs) and all-cause mortality
- Occurrence of Adverse Events (AEs) [ Time Frame: From IMP infusion until Day 30 ]Occurrence of any AEs from start of OCTAPLEX administration until end of study
- Body Temperature [ Time Frame: From day of IMP infusion until Day 30 ]Temperature measured during a 48-hour follow-up period after OCTAPLEX administration and at discharge
- Pulse [ Time Frame: From day of IMP infusion until Day 30 ]Pulse during a 48-hour follow-up period after OCTAPLEX administration and at discharge
- Respiration rate [ Time Frame: From day of IMP infusion until Day 30 ]Respiration rate during a 48-hour follow-up period after OCTAPLEX administration and at discharge
- Blood pressure [ Time Frame: From day of IMP infusion until Day 30 ]Blood pressure during a 48-hour follow-up period after OCTAPLEX administration and at discharge
- Change in Hgb [ Time Frame: 48 hours after administration of drug ]Change in haematologic parameters based on complete blood count (CBC), i.e., Hgb, haematocrit (Hct), red blood cells (RBC), white blood cells (WBC), platelets, from baseline to 48 hours after OCTAPLEX administration
- Change in haematocrit (Hct) [ Time Frame: 48 hours after administration of drug ]Change in Hct from baseline to 48 hours after OCTAPLEX administration
- Change in red blood cell (RBC) levels [ Time Frame: 48 hours after administration of drug ]Change in RBC levels from baseline to 48 hours after OCTAPLEX administration
- Change in white blood cell (WBC) levels [ Time Frame: 48 hours after administration of drug ]Change in WBC levels from baseline to 48 hours after OCTAPLEX administration
- Change in platelet levels [ Time Frame: 48 hours after administration of drug ]Change in platelet levels from baseline to 48 hours after OCTAPLEX administration
- Change in prothrombin time (PT) [ Time Frame: 24 hours after administration of drug ]Change in prothrombin time from baseline during a 24-hour follow-up period after OCTAPLEX administration
- Change in activated partial thromboplastin time (aPTT) [ Time Frame: 24 hours after administration of drug ]Change in aPTT from baseline during a 24-hour follow-up period after OCTAPLEX administration
- Change in Coagulation Parameters [ Time Frame: 24 hour follow-up period ]Change in coagulation parameters (international normalised ratio [INR], prothrombin time [PT], activated partial thromboplastin time [aPTT], coagulation factors II, VII, IX, and X levels) from baseline during a 24-hour follow-up period after OCTAPLEX administration
- Number of packed RBC concentrate (pRBC) transfusion [ Time Frame: 48 hours after administration of drug ]The number of patients receiving one or more pRBC transfusions during a 48-hour follow-up period after OCTAPLEX administration.
- Number of pRBC Units Transfused [ Time Frame: 48-hour follow-up period ]The number of pRBC units transfused per patient during a 48-hour follow-up period after OCTAPLEX administration
- Other Blood Products Used [ Time Frame: 48-hour follow-up period ]The use of other blood products and/or haemostatic agents during a 48-hour follow-up period after OCTAPLEX administration
- Use of Haemostatic Agents [ Time Frame: 48 hours after administration of drug ]The use of haemostatic agents during a 48-hour follow-up period after OCTAPLEX administration.
- Duration of Hospitalization [ Time Frame: From admission to discharge, approximately 1-3 weeks ]Duration of hospitalization
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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 anti- factor 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
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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
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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 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; heparin-induced, 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)
- Patients who received ticlopidine within 14 days, prasugrel within 7 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 enrollment
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04867837
| Contact: Sigurd Knaub, PhD | +41554512141 | Sigurd.Knaub@octapharma.com |
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| Responsible Party: | Octapharma |
| ClinicalTrials.gov Identifier: | NCT04867837 |
| Other Study ID Numbers: |
LEX-210 |
| First Posted: | April 30, 2021 Key Record Dates |
| Last Update Posted: | May 9, 2024 |
| Last Verified: | May 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Direct Oral Anticoagulant Factor Xa Inhibitor |
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Hemorrhage Pathologic Processes |