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.

Starting soon · Phase 3

Conditions studied: Blood Loss, Surgical, Coagulation Disorder

In brief

The goal of this clinical trial is to learn if VMX-C001 works to to allow blood clotting control in participants who take FXa Direct Oral Anticoagulants (DOACs) during surgery or other invasive procedures that carry a high risk of bleeding. The main question it aims to answer is: ● 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 a fixed dose of VMX-C001 to the usual treatment that would be given for the required procedure. Participants will: * Be given either a fixed dose of 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.

Key facts

Study ID

NCT07288489

Run by

VarmX B.V.

People needed

800

Starts

2026-03-01

Expected to finish

2031-01-01

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patient aged ≥18 years.
• The patient or legally authorised representative (LAR) has given written informed consent.
• The patient requires urgent surgery/procedure for which the risk of bleeding is considered high and for which haemostasis is considered necessary.
• The patient has a significant FXa DOAC level at the time of procedure.
• The patient would require treatment (usual pharmacological care) to restore coagulation for the required procedure.
• The patient must be willing to use appropriate contraception.

You may not qualify if…

• The patient is known for any reason, other than administration of a FXa DOAC, to have an increased risk of bleeding compared to a patient in a similar clinical situation.
• 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.
• The patient has received any of the prespecified medications not allowed in the 7 days prior to Randomisation.
• The patient was treated with an investigational drug <30 days or 5 half-lives, whichever is longer, prior to Screening.
• Expected survival, in the Investigator's judgement, is <3 months due to comorbidity.
• Patients in whom the Investigator considers it is not possible to estimate the expected blood loss.
• Known "Do Not Resuscitate" order or similar advanced directive.
• Cardiogenic shock at the time of screening unless related to the need for the required procedure.
• The patient has sepsis (including severe sepsis or septic shock) at the time of screening.
• The patient is pregnant or a lactating female.
• Known hypersensitivity to any component of VMX-C001 or hamster proteins.
• 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.
• Prior exposure to VMX-C001.

Where it is running

• 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

Full record on ClinicalTrials.gov

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