Phase 3 Trial of VMX-C001 vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
NCT ID: NCT07288489
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
800 participants
INTERVENTIONAL
2026-01-31
2031-01-31
Brief Summary
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● What is the proportion of participants in whom the stopping of bleeding was classed as good or excellent during the procedure, as judged by a group of experts who did not know which treatment was given?
Researchers will compare VMX-C001 to the usual treatment that would be given for the required procedure.
Participants will:
* Be given either VMX-C001 or usual treatment before they undergo the required procedure in theatre
* Have regular clinical assessments, including laboratory tests, during their hospital stay following the procedure
* Return to the clinic for a check-up and tests approximately 28 days after the procedure was conducted.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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VMX-C001
Participants will be administered VMX-C001 before undergoing the required procedure.
VMX-C001
VMX-C001 will be administered prior to commencement of procedure.
Usual Pharmacological Care
Participants will be given the usual treatment used by the site for patients receiving FXa DOACs when undergoing the required procedure.
Usual Pharmacological Care
Usual pharmacological care should be treatment planned to restore coagulation or support haemostasis for the required procedure.
Interventions
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VMX-C001
VMX-C001 will be administered prior to commencement of procedure.
Usual Pharmacological Care
Usual pharmacological care should be treatment planned to restore coagulation or support haemostasis for the required procedure.
Eligibility Criteria
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Inclusion Criteria
2. The patient or legally authorised representative (LAR) has given written informed consent.
3. The patient requires urgent surgery/procedure for which the risk of bleeding is considered high and for which haemostasis is considered necessary.
4. The patient has a significant FXa DOAC level at the time of procedure.
5. The patient would require treatment (usual pharmacological care) to restore coagulation for the required procedure.
6. The patient must be willing to use appropriate contraception.
Exclusion Criteria
2. The patient has received any non FXa DOAC anticoagulants within 7 days of Screening or has received heparin (UFH or LMWH) within 3 days of Screening.
3. The patient has received any of the prespecified medications not allowed in the 7 days prior to Randomisation.
4. The patient was treated with an investigational drug \<30 days or 5 half-lives, whichever is longer, prior to Screening.
5. Expected survival, in the Investigator's judgement, is \<3 months due to comorbidity.
6. Patients in whom the Investigator considers it is not possible to estimate the expected blood loss.
7. Known "Do Not Resuscitate" order or similar advanced directive.
8. Cardiogenic shock at the time of screening unless related to the need for the required procedure.
9. The patient has sepsis (including severe sepsis or septic shock) at the time of screening.
10. The patient is pregnant or a lactating female.
11. Known hypersensitivity to any component of VMX-C001 or hamster proteins.
12. Patients who, in the opinion of the Investigator, should not participate in the study for any other reason, or inability to comply with the protocol.
13. Prior exposure to VMX-C001.
18 Years
ALL
No
Sponsors
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VarmX B.V.
INDUSTRY
Responsible Party
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Locations
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Chandler Regional Medical Center (CRMC)
Chandler, Arizona, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
HonorHealth John C Lincoln Medical Center
Phoenix, Arizona, United States
Stanford Hospital and Clinics
Stanford, California, United States
Denver Metro Orthopedics, P.C. - Englewood Location
Englewood, Colorado, United States
Medical Center of the Rockies
Fort Collins, Colorado, United States
Christiana Care
Newark, Delaware, United States
University of South Florida
Tampa, Florida, United States
University of Iowa Health Care
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, United States
William Beaumont Hospital - Troy Campus
Troy, Michigan, United States
Duke University Medical Center
Durham, North Carolina, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Texas Tech University Health Sciences Center - El Paso
El Paso, Texas, United States
The University of Texas McGovern Medical School at Houston
Houston, Texas, United States
Royal Brisbane and Women's Hospital (RBWH)
Herston, Queensland, Australia
Mater Private Hospital
South Brisbane, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
St Vincent Hospital, Melbourne
Fitzroy, Victoria, Australia
Alfred Health, Melbourne
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Auckland City Hospital
Grafton, Auckand, New Zealand
Aotearoa Clinical Trials - Middlemore (ACTT) Middlemore Hospital
Papatoetoe, Auckland, New Zealand
Waikato Hospital
Hamilton, Waikato Region, New Zealand
Wellington Hospital
Newtown, Wellington Region, New Zealand
Countries
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Central Contacts
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Other Identifiers
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VMX-C001-06
Identifier Type: -
Identifier Source: org_study_id