A Phase 3 interventional study of Reltodecacog alfa and Usual Pharmacological Care in Blood Loss, Surgical and Coagulation Disorder, sponsored by VarmX B.V.. Recruiting at 77 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by VarmX B.V. · Phase 3, Interventional, and Treatment
Austria, Belgium, Canada, Germany, Hungary, Italy, Netherlands, Portugal, Romania, Serbia, Spain
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:
213 studies on the registry are indexed under Blood Loss, Surgical; 40 are open to participants now.
This study's planned enrollment of 800 is above the median of 80 across 160 interventional studies indexed under Blood Loss, Surgical.
Browse Blood Loss, Surgical studies →VarmX B.V. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be administered a fixed dose of reltodecacog alfa before undergoing the required procedure.
Drug: Reltodecacog alfa
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
A fixed dose of reltodecacog alfa will be administered prior to commencement of procedure.
Usual pharmacological care should be treatment planned to restore coagulation or support haemostasis for the required procedure.
Effect of VMX-C001 versus usual pharmacological care on haemostasis
Proportion of participants with good or excellent haemostatic efficacy during the required procedure.
Time frame: From start to end of required procedure (Day 1).
Effect of VMX-C001 versus usual pharmacological care on FXa DOAC induced anticoagulation measured by dilute prothrombin time (dPT).
Change in dPT.
Time frame: 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.
Time frame: 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.
Time frame: 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 \[life threatening\])
Time frame: 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.
Time frame: Between Randomisation and Pre-procedure timepoint (Day 1).
Plan to share: Yes — 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
Supporting information: 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.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Jan 2029, 29 months after the start.
How these figures are worked out, and which studies are left out of them.
Austria, Belgium, Canada, Germany, Hungary, Italy, Netherlands, Portugal, Romania, Serbia, Spain
Austria, Belgium, Canada, Germany, Hungary, Italy, Netherlands, Portugal, Romania, Serbia, Spain
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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