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. (EQUILIBRIX-S)
12. november 2026 oppdatert av: VarmX B.V.
En fase 3 prospektiv randomisert klinisk studie av VMX-C001 vs vanlig farmakologisk behandling hos pasienter som mottar et FXa-direkte oral antikoagulant (FXa DOAC) og som krever akutt kirurgi eller annen invasiv prosedyre som er forbundet med høy risiko for blødning, med eller uten planlagt administrering av heparin (EQUILIBRIX-S)
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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
800
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Head of Clinical Operations
- Telefonnummer: +43 664 88375193
- E-post: m.zorer@VarmX.com
Studiesteder
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Queensland
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Herston, Queensland, Australia, 4006
- Rekruttering
- Royal Brisbane and Women's Hospital (RBWH)
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South Brisbane, Queensland, Australia, 4101
- Rekruttering
- Mater Private Hospital
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Southport, Queensland, Australia, 4215
- Rekruttering
- Gold Coast University Hospital
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Victoria
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Fitzroy, Victoria, Australia, 3065
- Rekruttering
- St Vincent Hospital, Melbourne
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Melbourne, Victoria, Australia, 3004
- Rekruttering
- Alfred Health, Melbourne
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Western Australia
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Murdoch, Western Australia, Australia, 6150
- Rekruttering
- Fiona Stanley Hospital
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Leuven, Belgia, 3000
- Rekruttering
- UZ Leuven
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Walloon Brabant
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Ottignies, Walloon Brabant, Belgia, 1340
- Rekruttering
- Clinique Saint-Pierre- Ottignies
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Haskovo, Bulgaria, 6304
- Rekruttering
- Multiprofile Hospital for Active Treatment AD Haskovo
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Rousse, Bulgaria, 7002
- Rekruttering
- UMBAL Kanev AD
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Sofia, Bulgaria, 1431
- Rekruttering
- UMHAT Sveta Ekaterina EAD
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Stara Zagora, Bulgaria, 6003
- Rekruttering
- University Multiprofile Hospital for Active Treatment
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Vratsa, Bulgaria, 3000
- Rekruttering
- Multiprofile Hospital for Active Treatment Hristo Botev
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Pleven
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Pleven, Pleven, Bulgaria, 5800
- Rekruttering
- Multiprofile Hospital for Active Treatment Heart and Brain EAD
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Ontario
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Toronto, Ontario, Canada, M5B 1WB
- Rekruttering
- St Michael's Hospital
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Tartu, Estland, 50406
- Rekruttering
- Tartu University Hospital
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Arizona
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Chandler, Arizona, Forente stater, 85224
- Rekruttering
- Chandler Regional Medical Center (CRMC)
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Phoenix, Arizona, Forente stater, 85013
- Har ikke rekruttert ennå
- St. Joseph's Hospital and Medical Center
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Phoenix, Arizona, Forente stater, 85020
- Rekruttering
- HonorHealth John C Lincoln Medical Center
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California
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Stanford, California, Forente stater, 94305
- Har ikke rekruttert ennå
- Stanford Hospital and Clinics
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Colorado
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Englewood, Colorado, Forente stater, 80113
- Har ikke rekruttert ennå
- Denver Metro Orthopedics, P.C. - Englewood Location
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Fort Collins, Colorado, Forente stater, 80523
- Har ikke rekruttert ennå
- Medical Center of the Rockies
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Delaware
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Newark, Delaware, Forente stater, 19718
- Har ikke rekruttert ennå
- Christiana Care
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Florida
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Tampa, Florida, Forente stater, 33606
- Rekruttering
- University of South Florida
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Iowa
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Iowa City, Iowa, Forente stater, 52242
- Rekruttering
- University of Iowa Health Care
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Har ikke rekruttert ennå
- Massachusetts General Hospital
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Michigan
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Royal Oak, Michigan, Forente stater, 48073
- Har ikke rekruttert ennå
- Beaumont Hospital, Royal Oak
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Troy, Michigan, Forente stater, 48085
- Har ikke rekruttert ennå
- William Beaumont Hospital - Troy Campus
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North Carolina
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Durham, North Carolina, Forente stater, 27710
- Har ikke rekruttert ennå
- Duke University Medical Center
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Ohio
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Columbus, Ohio, Forente stater, 43210
- Rekruttering
- Ohio State McCampbell Outpatient Care
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73126
- Rekruttering
- The University of Oklahoma Health Sciences Center
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Texas
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El Paso, Texas, Forente stater, 79905
- Har ikke rekruttert ennå
- Texas Tech University Health Sciences Center - El Paso
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Houston, Texas, Forente stater, 77030
- Rekruttering
- Memorial Hermann Hospital-TMC Investigational Drugs Services Pharmacy
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Houston, Texas, Forente stater, 77030
- Har ikke rekruttert ennå
- The University of Texas McGovern Medical School at Houston
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Utah
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Murray, Utah, Forente stater, 84107
- Rekruttering
- Intermountain Medical Center
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Angers, Frankrike, 49933
- Rekruttering
- Centre Hospitalier Universitaire d'Angers
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Dijon, Frankrike, 21000
- Rekruttering
- Centre Hospitalier Universitaire CHU
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Nîmes, Frankrike, 30029
- Rekruttering
- CHU de Nimes - Hospital Universitaire Caremeau
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Paris, Frankrike, 75015
- Rekruttering
- Hospital Europeen Georges Pompidou HEGP
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Pierre-Bénite, Frankrike, 69495
- Rekruttering
- Centre Hospitalier Lyon-Sud
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Strasbourg, Frankrike, 67200
- Rekruttering
- Hopitaux Universitaires de Strasbourg -Hopital de Hautepierre
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Pays de la Loire Region
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Saint Priest En Jarez, Pays de la Loire Region, Frankrike, 42270
- Rekruttering
- CHU de Saint-Etienne - Hopital Bellevue
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Milan, Italia, 20142
- Rekruttering
- Azienda Ospedaliera San Paolo
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Monza, Italia, 20900
- Rekruttering
- Fondazione IRCCS San Gerardo dei Tintori
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Padova, Italia, 35128
- Rekruttering
- Azienda Osperdaliera di Padova
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Pavia, Italia, 27100
- Rekruttering
- Fondazione IRCCS Policlinico San Matteo
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Perugia, Italia, 06129
- Rekruttering
- Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
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Roma, Italia, 00168
- Rekruttering
- Fondazione Policlinico Universitario Agosti
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Rome, Italia, 00128
- Rekruttering
- Policlinico Universitario Campus Bio-Medico
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Trento, Italia, 38122
- Rekruttering
- Azienda Provinciale per i Servizi Sanitari - Presidio Ospedaliero S. Chiara
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Milan
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Rozzano, Milan, Italia, 20089
- Rekruttering
- IRCCS Humanitas Research Hospital
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Fukuoka-Shi, Fukuoka, Japan, 811-1313
- Rekruttering
- Fukuoka Neurosurgical Hospital
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Kumamoto-shi, Kumamoto, Japan, 861-8520
- Rekruttering
- Japanese Red Cross Kumamoto Hospital
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Kanagawa
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Kamakura-Shi, Kanagawa, Japan, 247-8533
- Rekruttering
- Shonan Kamakura General Hospital
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Maastricht, Nederland, 6229 HX
- Rekruttering
- Maastricht University Medical Centre - Cardiovascular Research Institute
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Auckand
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Grafton, Auckand, New Zealand, 1023
- Rekruttering
- Auckland City Hospital
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Auckland
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Papatoetoe, Auckland, New Zealand, 2025
- Rekruttering
- Aotearoa Clinical Trials - Middlemore (ACTT) Middlemore Hospital
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Waikato Region
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Hamilton, Waikato Region, New Zealand, 3204
- Rekruttering
- Waikato Hospital
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Wellington Region
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Newtown, Wellington Region, New Zealand, 6021
- Rekruttering
- Wellington Hospital
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Porto, Portugal
- Rekruttering
- Unidade Local de Saude Santo Antonio - Hospital de Santo Antonio
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Bucharest, Romania, 022328
- Rekruttering
- Institutul de Urgenta pentru Boli Cardiovasculare
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Bucharest, Romania, 041915
- Rekruttering
- Spitalul Clinic de Urgenta Bagdasar-Arseni
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Bucharest, Romania, 11461
- Rekruttering
- Spitalul Universitar de Urgenta Elias
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Timișoara, Romania, 300723
- Rekruttering
- Spitalul Clinic Judetean de Urgenta Pius Brinzeu Timisoara
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Belgrade, Serbia, 11000
- Rekruttering
- Klinicki Centar Srbije
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Kragujevac, Serbia, 34000
- Rekruttering
- University Clinical Center Kragujevac
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Novi Sad, Serbia, 21000
- Rekruttering
- Klinicki Centar Vojvodine
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Barcelona, Spania, 08036
- Rekruttering
- Hospital Clinic de Barcelona
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Barcelona, Spania, 08003
- Rekruttering
- Hospital del Mar
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Madrid, Spania, 28034
- Rekruttering
- Hospital Universitario Ramon y Cajal
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Madrid, Spania, 28046
- Rekruttering
- Hospital Universitario La Paz
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Málaga, Spania, 29010
- Rekruttering
- Hospital Universitario Virgen de la Victoria
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Valencia, Spania, 46015
- Rekruttering
- Hospital Arnau de Vilanova de Valencia
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Zaragoza, Spania, 50009
- Rekruttering
- Hospital Universitario Miguel Servet
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Birmingham, Storbritannia, B152TH
- Rekruttering
- University Hospitals Birmingham NHS Foundation Trust - New Queen Elizabeth Hospital
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Edinburgh, Storbritannia, EH16 4SA
- Rekruttering
- NHS Lothian - Royal Infirmary of Edinburgh
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Liverpool, Storbritannia, L7 8YE
- Rekruttering
- Royal Liverpool Broadgreen University Hospital Trust
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London, Storbritannia, SE5 9RS
- Rekruttering
- Kings College Hospital NHS Foundation Trust
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Newcastle upon Tyne, Storbritannia, NE1 4LP
- Rekruttering
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
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Gloucestershire
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Gloucester, Gloucestershire, Storbritannia, GL1 3NN
- Rekruttering
- Gloucestershire Hospitals NHS Foundation Trust - Gloucestershire Royal Hospital
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London
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London, London, Storbritannia, SE1 7EH
- Rekruttering
- Guys and St Thomas NHS Foundation Trust - St Thomas Hospital
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Náchod, Tsjekkia, 54701
- Rekruttering
- Oblastni nemocnice Nachod, a.s.
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Prague, Tsjekkia, 18081
- Rekruttering
- Fakultni Nemocnice Bulovka
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Dortmund, Tyskland, 44137
- Rekruttering
- Klinikum Dortmund gGmbH
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Murnau am Staffelsee, Tyskland
- Rekruttering
- BG Unfalklinik Murnau
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Saxony
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Dresden, Saxony, Tyskland, 01307
- Rekruttering
- Universitatsklinikum Carl Gustav Carus Dresden
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Budapest, Ungarn, 1082
- Rekruttering
- Semmelweis Egyetem Surgossegi Orvostar
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Debrecen, Ungarn, 4031
- Rekruttering
- Debreceni Egyetem Klinikai Kozpont III
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Kaposvár, Ungarn, 7400
- Rekruttering
- Somogy Megyei Kaposi Mor Oktato Korhaz
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Kecskemét, Ungarn, 6000
- Rekruttering
- Bacs-Kiskun Varmegyei Oktatokorhaz
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Pécs, Ungarn, 7624
- Rekruttering
- Tudomanyegyetem AOK Klinikai Kozpont Sebeszeti Klinika
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Székesfehérvár, Ungarn, H-8000
- Rekruttering
- Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
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Ózd, Ungarn, 3600
- Rekruttering
- Almasi Balogh Pal Korhaz
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Linz, Østerrike, 4020
- Rekruttering
- Ordensklinikum Linz Elisabethinen
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Reltodecacog alfa
Participants will be administered a fixed dose of reltodecacog alfa before undergoing the required procedure. |
A fixed dose of reltodecacog alfa will be administered prior to commencement of procedure. |
|
Aktiv komparator: Usual Pharmacological Care
Participants will be given the usual treatment used by the site for patients receiving FXa DOACs when undergoing the required procedure. |
Usual pharmacological care should be treatment planned to restore coagulation or support haemostasis for the required procedure. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Effect of VMX-C001 versus usual pharmacological care on haemostasis
Tidsramme: From start to end of required procedure (Day 1).
|
Proportion of participants with good or excellent haemostatic efficacy during the required procedure. |
From start to end of required procedure (Day 1).
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Effect of VMX-C001 versus usual pharmacological care on FXa DOAC induced anticoagulation measured by dilute prothrombin time (dPT).
Tidsramme: From Pre-procedure assessment compared to baseline (Randomisation) (Day 1).
|
Change in 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).
Tidsramme: From Pre-procedure assessment compared to baseline (Randomisation) (Day 1).
|
Change in 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.
Tidsramme: From start to end of required procedure (Day 1).
|
Percentage of expected blood loss. |
From start to end of required procedure (Day 1).
|
|
Effect of VMX-C001 versus usual pharmacological care on bleeding severity.
Tidsramme: Start of procedure (Day 1).
|
Bleeding severity at the Start of procedure using a 5 point scale (grades 0 [no bleeding] to 4 [life threatening]) |
Start of procedure (Day 1).
|
|
Effect of VMX-C001 versus usual pharmacological care on bleeding severity prior to procedure.
Tidsramme: Between Randomisation and Pre-procedure timepoint (Day 1).
|
Bleeding severity measured by blood loss. |
Between Randomisation and Pre-procedure timepoint (Day 1).
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. august 2026
Primær fullføring (Antatt)
1. januar 2029
Studiet fullført (Antatt)
1. januar 2031
Datoer for studieregistrering
Først innsendt
15. desember 2025
Først innsendt som oppfylte QC-kriteriene
15. desember 2025
Først lagt ut (Faktiske)
17. desember 2025
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. november 2026
Sist bekreftet
1. november 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VMX-C001-06
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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
IPD-delingstidsramme
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.
Tilgangskriterier for IPD-deling
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.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .