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Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor

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ClinicalTrials.gov Identifier: NCT04867837
Recruitment Status : Recruiting
First Posted : April 30, 2021
Last Update Posted : December 12, 2023
Sponsor:
Information provided by (Responsible Party):
Octapharma

Brief Summary:
This is a multicentre, prospective, randomised, double-blinded, group-sequential, parallel-group, adaptive design, phase 3 study to demonstrate the haemostatic efficacy and safety of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on DOAC therapy with factor Xa inhibitor. Patients will be randomised 1:1 to either of two study groups: low-dose vs. high-dose OCTAPLEX.

Condition or disease Intervention/treatment Phase
Acute Major Bleeding Drug: Octaplex Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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 : January 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Octaplex Low-dose
Participants to receive 1 Octaplex infusion intravenously
Drug: Octaplex
Four-factor prothrombin complex concentrate (4F-PCC)

Experimental: Octaplex High-dose
Participants to receive 1 Octaplex infusion intravenously
Drug: Octaplex
Four-factor prothrombin complex concentrate (4F-PCC)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 30-Day thromboembolic events (TEEs) [ Time Frame: 30 days ]
    30-day event rate of TEEs

  3. 30-Day all-cause mortality [ Time Frame: 30 days ]
    30 day event rate of all cause mortality events

  4. Occurrence of adverse events (AEs) [ Time Frame: From start of IMP infusion until Day 30 ]
    Occurrence of any AEs from start of OCTAPLEX administration until end of study

  5. 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

  6. 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

  7. 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

  8. 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


Other Outcome Measures:
  1. Change in Hgb [ Time Frame: 48 hours after administration of drug ]
    Change in Hgb from baseline to 48 hours after OCTAPLEX administration

  2. Change in haematocrit (Hct) [ Time Frame: 48 hours after administration of drug ]
    Change in Hct from baseline to 48 hours after OCTAPLEX administration

  3. 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

  4. 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

  5. Change in platelet levels [ Time Frame: 48 hours after administration of drug ]
    Change in platelet levels from baseline to 48 hours after OCTAPLEX administration

  6. 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

  7. 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

  8. Change in coagulation factors II, VII, IX and X levels [ Time Frame: 24 hours after administration of drug ]
    Change in coagulation factors from baseline during a 24-hour follow-up period after OCTAPLEX administration

  9. Number of packed RBC concentrate (pRBC) transfusions [ 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.

  10. Number of pRBC units transfused [ Time Frame: 48 hours after administration of drug ]
    The number of RBC untis transfused per patient during a 48-hour follow-up period after OCTAPLEX administration

  11. Use of other blood products [ Time Frame: 48 hours after administration of drug ]
    The use of other blood products during a 48-hour follow-up period after OCTAPLEX administration.

  12. 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.

  13. Duration of hospitalisation [ Time Frame: From admission to discharge, approximately 1-3 weeks ]
    Duration of hospitalisation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who received or who are believed by the investigator to have received a dose of oral factor Xa inhibitor
  • 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
  • Patients who have acute major bleeding defined as follows:

    • Bleeding that is potentially 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, 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
  • Patients with baseline anti-factor Xa activity equivalent to at least 100 ng/mL according to the available test (e.g., chromogenic assay)

Exclusion Criteria:

  • Patients with bleeding that is immediately life-threatening
  • 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
  • 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, clopidogrel within 5 days, ticagrelor within 5 days 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 or an estimated intracerebral haematoma volume of more than 60 mL
  • Patients with expected survival of less than 3 days
  • Patients scheduled to undergo surgery in less than 12 hours, with the exception of some minor/invasive procedures that are allowed for diagnostic or therapeutic reasons
  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Sigurd Knaub, PhD +41554512141 Sigurd.Knaub@octapharma.com

Locations
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Sponsors and Collaborators
Octapharma
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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: December 12, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Octapharma:
Direct Oral Anticoagulant
Factor Xa Inhibitor
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes