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. (EQUILIBRIX-S)

A Phase 3 Prospective Randomised Clinical Trial of VMX-C001 vs Usual Pharmacological Care in Patients Receiving a FXa Direct Oral Anticoagulant (FXa DOAC) Who Require Urgent Surgery or Other Invasive Procedure That is Associated With a High Risk of Bleeding, With or Without Planned Administration of Heparin (EQUILIBRIX-S)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coagulation Disorder; Blood Loss, Surgical
• Intervention / Treatment: Drug: Usual Pharmacological Care; Drug: VMX-C001

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Head of Clinical Operations; Phone Number: +43 664 88375193; Email: m.zorer@VarmX.com

Study Locations

• Australia
  • Queensland
    • Herston, Queensland, Australia, 4006
      • Royal Brisbane and Women's Hospital (RBWH)
    • South Brisbane, Queensland, Australia, 4101
      • Mater Private Hospital
    • Southport, Queensland, Australia, 4215
      • Gold Coast University Hospital
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent Hospital, Melbourne
    • Melbourne, Victoria, Australia, 3004
      • Alfred Health, Melbourne
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
• New Zealand
  • Auckand
    • Grafton, Auckand, New Zealand, 1023
      • Auckland City Hospital
  • Auckland
    • Papatoetoe, Auckland, New Zealand, 2025
      • Aotearoa Clinical Trials - Middlemore (ACTT) Middlemore Hospital
  • Waikato Region
    • Hamilton, Waikato Region, New Zealand, 3204
      • Waikato Hospital
  • Wellington Region
    • Newtown, Wellington Region, New Zealand, 6021
      • Wellington Hospital
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Chandler Regional Medical Center (CRMC)
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital and Medical Center
    • Phoenix, Arizona, United States, 85020
      • HonorHealth John C Lincoln Medical Center
  • California
    • Stanford, California, United States, 94305
      • Stanford Hospital and Clinics
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Denver Metro Orthopedics, P.C. - Englewood Location
    • Fort Collins, Colorado, United States, 80523
      • Medical Center of the Rockies
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care
  • Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Health Care
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital, Royal Oak
    • Troy, Michigan, United States, 48085
      • William Beaumont Hospital - Troy Campus
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73126
      • The University of Oklahoma Health Sciences Center
  • Texas
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health Sciences Center - El Paso
    • Houston, Texas, United States, 77030
      • The University of Texas McGovern Medical School at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female patient aged ≥18 years.
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:

1. 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.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Pharmacological Care; Participants will be given the usual treatment used by the site for patients receiving FXa DOACs when undergoing the required procedure.	Drug: Usual Pharmacological Care; Usual pharmacological care should be treatment planned to restore coagulation or support haemostasis for the required procedure.
Experimental: VMX-C001; Participants will be administered a fixed dose of VMX-C001 before undergoing the required procedure.	Drug: VMX-C001; A fixed dose of VMX-C001 will be administered prior to commencement of procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of VMX-C001 versus usual pharmacological care on haemostasis	Proportion of participants with good or excellent haemostatic efficacy during the required procedure.	From start to end of required procedure (Day 1).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of VMX-C001 versus usual pharmacological care on FXa DOAC induced anticoagulation measured by dilute prothrombin time (dPT).	Change in dPT.	From Pre-procedure assessment compared to baseline (Randomisation) (Day 1).
Effect of VMX-C001 versus usual pharmacological care on FXa DOAC induced anticoagulation as measured by dilute Russell Viper Venom Time (dRVVT).	Change in dRVVT.	From Pre-procedure assessment compared to baseline (Randomisation) (Day 1).
Effect of VMX-C001 versus usual pharmacological care on the extent of actual blood loss compared to expected blood loss during procedure.	Percentage of expected blood loss.	From start to end of required procedure (Day 1).
Effect of VMX-C001 versus usual pharmacological care on bleeding severity.	Bleeding severity at the Start of procedure using a 5 point scale (grades 0 [no bleeding] to 4 [life threatening])	Start of procedure (Day 1).
Effect of VMX-C001 versus usual pharmacological care on bleeding severity prior to procedure.	Bleeding severity measured by blood loss.	Between Randomisation and Pre-procedure timepoint (Day 1).

Collaborators and Investigators

• Sponsor: VarmX B.V.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2031

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Surgery; Direct oral anticoagulant (DOAC); Human coagulation factor
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Hematologic Diseases; Hemorrhagic Disorders; Intraoperative Complications; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Hemostatic Disorders; Blood Loss, Surgical
• Other Study ID Numbers: VMX-C001-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: VarmX will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external, verified, qualified scientific and medical researchers. Information on the process and requirements for submitting a voluntary data sharing request for IPD can be obtained from info@varmx.com
• IPD Sharing Time Frame: Requests for sharing of IPD will be considered once review by major regulatory authorities is complete and the primary publication is available. Sharing will be allowed for a period of 36 months after the primary publication is available.
• IPD Sharing Access Criteria: The proposed research should seek to answer a previously unanswered important medical or scientific question (to be stated in the request). VarmX will comply with applicable country-specific and other applicable laws and regulations when considering requests for sharing of IPD and this may prevent sharing of IPD. Appropriately anonymised IPD will be made available following approval of the request and only if the researcher has executed an appropriate data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No