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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

VarmX B.V.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15]

Decision date (initial)

2026-05-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

VarmX B.V.

External identifiers

EU CT number

2025-521632-12-00

ClinicalTrials.gov

NCT07288489

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

To evaluate the effect of VMX-C001 versus usual pharmacological care on haemostasis during urgent surgery or invasive procedure in participants on FXa DOACs

Conditions and MedDRA coding

Patients on Factor Xa inhibitor treatment needing an urgent intervention associated with a high risk of bleeding

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Pharmaceuticals And Medical Devices Agency, Food And Drug Administration

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Male or female patient aged ≥18 years and with a body weight of ≥40 kg.
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. Usual pharmacological care for urgent surgery/required procedure for the patient would include one of the prespecified medications.
6. Male patients must be willing to use appropriate contraception, such as condom, and to refrain from sperm donation until 90 days after study drug administration. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test at Screening and agree to use highly effective contraception from Screening through to 28 days following administration of study treatment.

Exclusion criteria 13

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 other than the mortality risk from the required urgent surgery/procedure, i.e. if the Investigator judges that the required procedure carries a risk of mortality in the next three months but otherwise the patient would be expected to survive ≥ 3 months, the patient will not be excluded from the trial.
6. Patients in whom the Investigator considers it is not possible to estimate the expected blood loss, such as a patient with polytrauma.
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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants with good or excellent haemostatic efficacy during the required procedure as determined by an independent blinded EAC.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

VarmX B.V.

Sponsor organisation

VarmX B.V.

Address

Emmy Noetherweg 2

City

Leiden

Postcode

2333 BK

Country

Netherlands

Scientific contact point

Organisation

VarmX B.V.

Contact name

Clinical Trial Information Desk

Public contact point

Organisation

VarmX B.V.

Contact name

Clinical Trial Information Desk

Third parties 4

Locations

15 EU/EEA countries · 86 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 173 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications