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.

NCT07288489 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: VMX-C001-06
• Study Type: interventional
• Target: 800
• Locations: 3 countries
• Sites: 26

Brief Summary

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.

Conditions

Blood Loss, Surgical; Coagulation Disorder

Keywords

Direct oral anticoagulant (DOAC); Human coagulation factor; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Effect of VMX-C001 versus usual pharmacological care on FXa DOAC induced anticoagulation measured by dilute prothrombin time (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).

  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.

  From start to end of required procedure (Day 1).

• Effect of VMX-C001 versus usual pharmacological care on bleeding severity.

  Start of procedure (Day 1).

• Effect of VMX-C001 versus usual pharmacological care on bleeding severity prior to procedure.

  Between Randomisation and Pre-procedure timepoint (Day 1).

Study Arms (2)

VMX-C001

EXPERIMENTAL

Participants will be administered a fixed dose of VMX-C001 before undergoing the required procedure.

Drug: VMX-C001

Usual Pharmacological Care

ACTIVE COMPARATOR

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

Interventions

VMX-C001 DRUG

A fixed dose of VMX-C001 will be administered prior to commencement of procedure.

VMX-C001

Usual Pharmacological Care DRUG

Usual pharmacological care should be treatment planned to restore coagulation or support haemostasis for the required procedure.

Usual Pharmacological Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• VarmX B.V.: lead

Study Sites (26)

Chandler Regional Medical Center (CRMC)

Chandler, Arizona, 85224, United States

Location

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

HonorHealth John C Lincoln Medical Center

Phoenix, Arizona, 85020, United States

Location

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

Denver Metro Orthopedics, P.C. - Englewood Location

Englewood, Colorado, 80113, United States

Location

Medical Center of the Rockies

Fort Collins, Colorado, 80523, United States

Location

Christiana Care

Newark, Delaware, 19718, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beaumont Hospital, Royal Oak

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital - Troy Campus

Troy, Michigan, 48085, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73126, United States

Location

Texas Tech University Health Sciences Center - El Paso

El Paso, Texas, 79905, United States

Location

The University of Texas McGovern Medical School at Houston

Houston, Texas, 77030, United States

Location

Royal Brisbane and Women's Hospital (RBWH)

Herston, Queensland, 4006, Australia

Location

Mater Private Hospital

South Brisbane, Queensland, 4101, Australia

Location

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

Location

St Vincent Hospital, Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Alfred Health, Melbourne

Melbourne, Victoria, 3004, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

Auckland City Hospital

Grafton, Auckand, 1023, New Zealand

Location

Aotearoa Clinical Trials - Middlemore (ACTT) Middlemore Hospital

Papatoetoe, Auckland, 2025, New Zealand

Location

Waikato Hospital

Hamilton, Waikato Region, 3204, New Zealand

Location

Wellington Hospital

Newtown, Wellington Region, 6021, New Zealand

Location

MeSH Terms

Conditions

Blood Loss, Surgical; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Head of Clinical Operations

CONTACT

+43 664 88375193; m.zorer@VarmX.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 17, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2031
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

US (16); NZ (4); AU (6)