VMX-C001 for Blood Loss

(EQUILIBRIX-S Trial)

Not yet recruiting at 25 trial locations

Overseen By Head of Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VarmX B.V.

Must be taking: FXa DOACs

Must not be taking: Non FXa DOACs, Heparin

Disqualifiers: Increased bleeding risk, Sepsis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, VMX-C001, to control bleeding during surgeries or procedures for patients on certain blood thinners (FXa DOACs). Researchers aim to determine if VMX-C001 is as effective as or better than the usual treatment in stopping bleeding. Participants will receive either VMX-C001 or the standard treatment and will have follow-up check-ups after the procedure. This trial suits individuals needing urgent surgery or a procedure with a high risk of bleeding who are already using blood thinners. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications to join the trial?

The trial requires that you have not taken any non-FXa DOAC anticoagulants within 7 days before screening and no heparin within 3 days before screening. If you are on these medications, you may need to stop them to participate.

Is there any evidence suggesting that VMX-C001 is likely to be safe for humans?

Research shows that VMX-C001 is generally well-tolerated. One study demonstrated that VMX-C001 completely stopped bleeding caused by rivaroxaban, a common blood thinner. Although it affected a blood clotting test called aPTT, it did not cause serious bleeding problems on its own.

Early studies reported no major side effects from VMX-C001. Safety checks included monitoring weight, food intake, heart and lung functions, and blood tests, all of which revealed no major concerns.

Overall, the available data suggests that VMX-C001 is safe for humans, with no major adverse events reported in studies so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care, which often involves typical anticoagulant management, VMX-C001 targets blood loss by potentially offering a new way to manage patients on FXa direct oral anticoagulants (DOACs) during procedures. Researchers are excited about VMX-C001 because it might provide a more effective, targeted approach to control bleeding, which can be a significant risk in surgical settings for patients on these medications. By focusing on a different mechanism to reduce blood loss, VMX-C001 could enhance safety and outcomes for these patients, distinguishing it from current pharmacological care options.

What evidence suggests that VMX-C001 might be an effective treatment for blood loss?

Research has shown that VMX-C001, which participants in this trial may receive, can help control bleeding when Rivaroxaban, a blood thinner, causes excessive bleeding. Studies have found that VMX-C001 can completely reverse increased bleeding and blood loss. Although VMX-C001 can prolong some blood test times, such as aPTT, this does not predict its effect on bleeding. This suggests that VMX-C001 might help manage blood loss during procedures for individuals taking certain blood thinners. Early evidence supports its potential to stop bleeding effectively. Participants in another arm of this trial will receive the usual pharmacological care for managing blood loss. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients on FXa Direct Oral Anticoagulants who need urgent surgery with a high risk of bleeding. They will be tested to see if VMX-C001 can help control blood clotting during their procedure.

Inclusion Criteria

I need urgent surgery with a high risk of bleeding where stopping the bleeding is crucial.

I have a noticeable blood thinner level from my medication during the procedure.

I am 18 years old or older.

Exclusion Criteria

I have a higher risk of bleeding not due to taking blood thinners.

Known 'Do Not Resuscitate' order or similar advanced directive

I haven't taken any non FXa blood thinners in the last 7 days or heparin in the last 3 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-procedure

Participants are administered either VMX-C001 or usual treatment before undergoing the required procedure

1 day

1 visit (in-person)

Procedure

Participants undergo the required surgery or invasive procedure with monitoring of bleeding control

1 day

1 visit (in-person)

Post-procedure Hospital Stay

Participants have regular clinical assessments, including laboratory tests, during their hospital stay following the procedure

Varies

Follow-up

Participants return to the clinic for a check-up and tests approximately 28 days after the procedure was conducted

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• VMX-C001

Trial Overview

The study compares VMX-C001, a potential new treatment, against the usual care given to manage bleeding during surgery in patients taking anticoagulants. Success is measured by how well bleeding is controlled as judged by blinded experts.

How Is the Trial Designed?

Group I: VMX-C001 Experimental Treatment 1 Intervention

Participants will be administered VMX-C001 before undergoing the required procedure.

Group II: Usual Pharmacological Care Active Control 1 Intervention

Participants will be given the usual treatment used by the site for patients receiving FXa DOACs when undergoing the required procedure.

Who Is Running the Clinical Trial?

VarmX B.V.

Lead Sponsor

Trials

3

Recruited

160+

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S0006497124039429

Vmx-C001 Prevents Rivaroxaban-Induced Bleeding in a ...

VMX-C001 alone has no impact on bleeding outcomes, despite prolonging the aPTT. Changes in PT/aPTT appear not to predict the effect of VMX-C001 ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06517563

Study Details | NCT06517563 | Effects of VMX-C001 on the ...

A single centre, open-label study to assess the effects of VMX-C001 in combination with an oral FXa DOAC on the efficacy of Unfractionated Heparin (UFH) and ...

3.

varmx.com

varmx.com/conferences-events/varmx-presents-new-data-at-isth-2024/

VarmX Presents New Data at ISTH 2024

The data presented by Daniël Verhoef, VarmX's Director of Research, show that VMX-C001 completely reversed the increase in bleeding time and blood loss induced ...

4.

ash.confex.com

ash.confex.com/ash/2024/webprogram/Paper205141.html

Paper: Vmx-C001 Prevents Rivaroxaban-Induced Bleeding ...

VMX-C001 alone has no impact on bleeding outcomes, despite prolonging the aPTT. Changes in PT/aPTT appear not to predict the effect of VMX-C001 on bleeding.

5.

researchgate.net

researchgate.net/publication/386471137_Vmx-C001_Prevents_Rivaroxaban-Induced_Bleeding_in_a_Liver_Injury_Model_in_Cynomolgus_Monkeys

Vmx-C001 Prevents Rivaroxaban-Induced Bleeding in a ...

VMX-C001 alone has no impact on bleeding outcomes, despite prolonging the aPTT. Changes in PT/aPTT appear not to predict the effect of VMX-C001 ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07288489

Phase 3 Trial of VMX-C001 vs Usual Pharmacological ...

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 ...

7.

varmx.com

varmx.com/wp-content/uploads/2024/03/ISTH2022_poster.pdf

Preclinical safety and toxicokinetics of VMX-C001

Safety parameters included: clinical signs, body weight, food consumption, ECGs, respiratory function, hematology, coagulation (including TAT, D-dimer and ...

8.

researchgate.net

researchgate.net/publication/386496945_Phase_1_Study_of_the_Safety_and_Pharmacodynamics_of_a_Single_Dose_of_Vmx-C001_in_Healthy_Subjects_with_and_without_FXa_Direct_Oral_Anticoagulants

(PDF) Phase 1 Study of the Safety and Pharmacodynamics ...

VMX-C001 alone has no impact on bleeding outcomes, despite prolonging the aPTT. Changes in PT/aPTT appear not to predict the effect of VMX-C001 ...