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 uppdaterad av: VarmX B.V.
En fas 3 prospektiv randomiserad klinisk prövning av VMX-C001 jämfört med vanlig farmakologisk vård hos patienter som behandlas med FXa-direkta orala antikoagulantia (FXa DOAC) och som kräver akut kirurgi eller annan invasiv procedur som är förknippad med hög risk för blödning, med eller utan planerad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
800
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Head of Clinical Operations
- Telefonnummer: +43 664 88375193
- E-post: m.zorer@VarmX.com
Studieorter
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Queensland
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Herston, Queensland, Australien, 4006
- Rekrytering
- Royal Brisbane and Women's Hospital (RBWH)
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South Brisbane, Queensland, Australien, 4101
- Rekrytering
- Mater Private Hospital
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Southport, Queensland, Australien, 4215
- Rekrytering
- Gold Coast University Hospital
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Victoria
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Fitzroy, Victoria, Australien, 3065
- Rekrytering
- St Vincent Hospital, Melbourne
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Melbourne, Victoria, Australien, 3004
- Rekrytering
- Alfred Health, Melbourne
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Western Australia
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Murdoch, Western Australia, Australien, 6150
- Rekrytering
- Fiona Stanley Hospital
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Leuven, Belgien, 3000
- Rekrytering
- UZ Leuven
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Walloon Brabant
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Ottignies, Walloon Brabant, Belgien, 1340
- Rekrytering
- Clinique Saint-Pierre- Ottignies
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Haskovo, Bulgarien, 6304
- Rekrytering
- Multiprofile Hospital for Active Treatment AD Haskovo
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Rousse, Bulgarien, 7002
- Rekrytering
- UMBAL Kanev AD
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Sofia, Bulgarien, 1431
- Rekrytering
- UMHAT Sveta Ekaterina EAD
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Stara Zagora, Bulgarien, 6003
- Rekrytering
- University Multiprofile Hospital for Active Treatment
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Vratsa, Bulgarien, 3000
- Rekrytering
- Multiprofile Hospital for Active Treatment Hristo Botev
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Pleven
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Pleven, Pleven, Bulgarien, 5800
- Rekrytering
- Multiprofile Hospital for Active Treatment Heart and Brain EAD
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Tartu, Estland, 50406
- Rekrytering
- Tartu University Hospital
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Angers, Frankrike, 49933
- Rekrytering
- Centre Hospitalier Universitaire d'Angers
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Dijon, Frankrike, 21000
- Rekrytering
- Centre Hospitalier Universitaire CHU
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Nîmes, Frankrike, 30029
- Rekrytering
- CHU de Nimes - Hospital Universitaire Caremeau
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Paris, Frankrike, 75015
- Rekrytering
- Hospital Europeen Georges Pompidou HEGP
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Pierre-Bénite, Frankrike, 69495
- Rekrytering
- Centre Hospitalier Lyon-Sud
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Strasbourg, Frankrike, 67200
- Rekrytering
- 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
- Rekrytering
- CHU de Saint-Etienne - Hopital Bellevue
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Arizona
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Chandler, Arizona, Förenta staterna, 85224
- Rekrytering
- Chandler Regional Medical Center (CRMC)
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Phoenix, Arizona, Förenta staterna, 85013
- Har inte rekryterat ännu
- St. Joseph's Hospital and Medical Center
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Phoenix, Arizona, Förenta staterna, 85020
- Rekrytering
- HonorHealth John C Lincoln Medical Center
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California
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Stanford, California, Förenta staterna, 94305
- Har inte rekryterat ännu
- Stanford Hospital and Clinics
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Colorado
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Englewood, Colorado, Förenta staterna, 80113
- Har inte rekryterat ännu
- Denver Metro Orthopedics, P.C. - Englewood Location
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Fort Collins, Colorado, Förenta staterna, 80523
- Har inte rekryterat ännu
- Medical Center of the Rockies
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Delaware
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Newark, Delaware, Förenta staterna, 19718
- Har inte rekryterat ännu
- Christiana Care
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Florida
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Tampa, Florida, Förenta staterna, 33606
- Rekrytering
- University of South Florida
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Iowa
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Iowa City, Iowa, Förenta staterna, 52242
- Rekrytering
- University of Iowa Health Care
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02114
- Har inte rekryterat ännu
- Massachusetts General Hospital
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Michigan
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Royal Oak, Michigan, Förenta staterna, 48073
- Har inte rekryterat ännu
- Beaumont Hospital, Royal Oak
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Troy, Michigan, Förenta staterna, 48085
- Har inte rekryterat ännu
- William Beaumont Hospital - Troy Campus
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North Carolina
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Durham, North Carolina, Förenta staterna, 27710
- Har inte rekryterat ännu
- Duke University Medical Center
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Ohio
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Columbus, Ohio, Förenta staterna, 43210
- Rekrytering
- Ohio State McCampbell Outpatient Care
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73126
- Rekrytering
- The University of Oklahoma Health Sciences Center
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Texas
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El Paso, Texas, Förenta staterna, 79905
- Har inte rekryterat ännu
- Texas Tech University Health Sciences Center - El Paso
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Houston, Texas, Förenta staterna, 77030
- Rekrytering
- Memorial Hermann Hospital-TMC Investigational Drugs Services Pharmacy
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Houston, Texas, Förenta staterna, 77030
- Har inte rekryterat ännu
- The University of Texas McGovern Medical School at Houston
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Utah
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Murray, Utah, Förenta staterna, 84107
- Rekrytering
- Intermountain Medical Center
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Milan, Italien, 20142
- Rekrytering
- Azienda Ospedaliera San Paolo
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Monza, Italien, 20900
- Rekrytering
- Fondazione IRCCS San Gerardo dei Tintori
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Padova, Italien, 35128
- Rekrytering
- Azienda Osperdaliera di Padova
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Pavia, Italien, 27100
- Rekrytering
- Fondazione IRCCS Policlinico San Matteo
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Perugia, Italien, 06129
- Rekrytering
- Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
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Roma, Italien, 00168
- Rekrytering
- Fondazione Policlinico Universitario Agosti
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Rome, Italien, 00128
- Rekrytering
- Policlinico Universitario Campus Bio-Medico
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Trento, Italien, 38122
- Rekrytering
- Azienda Provinciale per i Servizi Sanitari - Presidio Ospedaliero S. Chiara
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Milan
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Rozzano, Milan, Italien, 20089
- Rekrytering
- IRCCS Humanitas Research Hospital
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Fukuoka-Shi, Fukuoka, Japan, 811-1313
- Rekrytering
- Fukuoka Neurosurgical Hospital
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Kumamoto-shi, Kumamoto, Japan, 861-8520
- Rekrytering
- Japanese Red Cross Kumamoto Hospital
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Kanagawa
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Kamakura-Shi, Kanagawa, Japan, 247-8533
- Rekrytering
- Shonan Kamakura General Hospital
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Ontario
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Toronto, Ontario, Kanada, M5B 1WB
- Rekrytering
- St Michael's Hospital
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Maastricht, Nederländerna, 6229 HX
- Rekrytering
- Maastricht University Medical Centre - Cardiovascular Research Institute
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Auckand
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Grafton, Auckand, Nya Zeeland, 1023
- Rekrytering
- Auckland City Hospital
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Auckland
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Papatoetoe, Auckland, Nya Zeeland, 2025
- Rekrytering
- Aotearoa Clinical Trials - Middlemore (ACTT) Middlemore Hospital
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Waikato Region
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Hamilton, Waikato Region, Nya Zeeland, 3204
- Rekrytering
- Waikato Hospital
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Wellington Region
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Newtown, Wellington Region, Nya Zeeland, 6021
- Rekrytering
- Wellington Hospital
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Porto, Portugal
- Rekrytering
- Unidade Local de Saude Santo Antonio - Hospital de Santo Antonio
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Bucharest, Rumänien, 022328
- Rekrytering
- Institutul de Urgenta pentru Boli Cardiovasculare
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Bucharest, Rumänien, 041915
- Rekrytering
- Spitalul Clinic de Urgenta Bagdasar-Arseni
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Bucharest, Rumänien, 11461
- Rekrytering
- Spitalul Universitar de Urgenta Elias
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Timișoara, Rumänien, 300723
- Rekrytering
- Spitalul Clinic Judetean de Urgenta Pius Brinzeu Timisoara
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Belgrade, Serbien, 11000
- Rekrytering
- Klinicki Centar Srbije
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Kragujevac, Serbien, 34000
- Rekrytering
- University Clinical Center Kragujevac
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Novi Sad, Serbien, 21000
- Rekrytering
- Klinicki Centar Vojvodine
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Barcelona, Spanien, 08036
- Rekrytering
- Hospital Clinic de Barcelona
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Barcelona, Spanien, 08003
- Rekrytering
- Hospital del Mar
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Madrid, Spanien, 28034
- Rekrytering
- Hospital Universitario Ramon y Cajal
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Madrid, Spanien, 28046
- Rekrytering
- Hospital Universitario La Paz
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Málaga, Spanien, 29010
- Rekrytering
- Hospital Universitario Virgen de la Victoria
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Valencia, Spanien, 46015
- Rekrytering
- Hospital Arnau de Vilanova de Valencia
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Zaragoza, Spanien, 50009
- Rekrytering
- Hospital Universitario Miguel Servet
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Birmingham, Storbritannien, B152TH
- Rekrytering
- University Hospitals Birmingham NHS Foundation Trust - New Queen Elizabeth Hospital
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Edinburgh, Storbritannien, EH16 4SA
- Rekrytering
- NHS Lothian - Royal Infirmary of Edinburgh
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Liverpool, Storbritannien, L7 8YE
- Rekrytering
- Royal Liverpool Broadgreen University Hospital Trust
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London, Storbritannien, SE5 9RS
- Rekrytering
- Kings College Hospital NHS Foundation Trust
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Newcastle upon Tyne, Storbritannien, NE1 4LP
- Rekrytering
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
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Gloucestershire
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Gloucester, Gloucestershire, Storbritannien, GL1 3NN
- Rekrytering
- Gloucestershire Hospitals NHS Foundation Trust - Gloucestershire Royal Hospital
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London
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London, London, Storbritannien, SE1 7EH
- Rekrytering
- Guys and St Thomas NHS Foundation Trust - St Thomas Hospital
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Náchod, Tjeckien, 54701
- Rekrytering
- Oblastni nemocnice Nachod, a.s.
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Prague, Tjeckien, 18081
- Rekrytering
- Fakultni Nemocnice Bulovka
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Dortmund, Tyskland, 44137
- Rekrytering
- Klinikum Dortmund gGmbH
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Murnau am Staffelsee, Tyskland
- Rekrytering
- BG Unfalklinik Murnau
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Saxony
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Dresden, Saxony, Tyskland, 01307
- Rekrytering
- Universitatsklinikum Carl Gustav Carus Dresden
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Budapest, Ungern, 1082
- Rekrytering
- Semmelweis Egyetem Surgossegi Orvostar
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Debrecen, Ungern, 4031
- Rekrytering
- Debreceni Egyetem Klinikai Kozpont III
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Kaposvár, Ungern, 7400
- Rekrytering
- Somogy Megyei Kaposi Mor Oktato Korhaz
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Kecskemét, Ungern, 6000
- Rekrytering
- Bacs-Kiskun Varmegyei Oktatokorhaz
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Pécs, Ungern, 7624
- Rekrytering
- Tudomanyegyetem AOK Klinikai Kozpont Sebeszeti Klinika
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Székesfehérvár, Ungern, H-8000
- Rekrytering
- Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
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Ózd, Ungern, 3600
- Rekrytering
- Almasi Balogh Pal Korhaz
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Linz, Österrike, 4020
- Rekrytering
- Ordensklinikum Linz Elisabethinen
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Effect of VMX-C001 versus usual pharmacological care on haemostasis
Tidsram: 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).
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Effect of VMX-C001 versus usual pharmacological care on FXa DOAC induced anticoagulation measured by dilute prothrombin time (dPT).
Tidsram: 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).
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: Between Randomisation and Pre-procedure timepoint (Day 1).
|
Bleeding severity measured by blood loss. |
Between Randomisation and Pre-procedure timepoint (Day 1).
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 augusti 2026
Primärt slutförande (Beräknad)
1 januari 2029
Avslutad studie (Beräknad)
1 januari 2031
Studieregistreringsdatum
Först inskickad
15 december 2025
Först inskickad som uppfyllde QC-kriterierna
15 december 2025
Första postat (Faktisk)
17 december 2025
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 november 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 november 2026
Senast verifierad
1 november 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- VMX-C001-06
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .