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RecruitingPhase 3

Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.

VarmX B.V. · NCT07288489

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
800
US sites recruiting
8
Study start
August 18, 2026
Record last updated
October 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The goal of this clinical trial is to learn if reltodecacog alfa (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 reltodecacog alfa (VMX-C001) to the usual treatment that would be given for the required procedure.

Participants will

  • Be given either a fixed dose of reltodecacog alfa (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.

Being studied: Reltodecacog alfa; Usual Pharmacological Care

Conditions: Blood Loss, Surgical; Coagulation Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Recruiting US locations

Study contacts (from the official record)

  • Head of Clinical Operations · +43 664 88375193 · m.zorer@VarmX.com
Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual… (NCT07288489) | Bored Studies