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Effekten av Atenativ hos pasienter med medfødt antitrombinmangel som gjennomgår kirurgi eller fødsel

25. september 2026 oppdatert av: Octapharma

En multisenter, prospektiv, åpen, ukontrollert fase 3-studie for å vurdere effektiviteten, sikkerheten og farmakokinetikken til Atenativ hos pasienter med medfødt antitrombinmangel som gjennomgår kirurgi eller fødsel

The goal of this study is to assess the incidence of the composite of thrombotic events (TEs) and thromboembolic events (TEEs) in patients with congenital antithrombin deficiency under when they receive Atenativ for surgical procedures or parturition.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

38

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Armenia
      • Yerevan, Armenia
        • Rekruttering
        • Yeolyan Hematology and Oncology Centre
  • Forente stater
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20057
        • Rekruttering
        • Georgetown University Hospital
    • Florida
      • Miami, Florida, Forente stater, 33124
        • Rekruttering
        • University of Miami, Miller School of Medicine
    • Illinois
      • Peoria, Illinois, Forente stater, 61615
        • Rekruttering
        • Bleeding and Clotting Disorders Institute
    • New York
      • New York, New York, Forente stater, 10065
        • Rekruttering
        • Weill Cornell Medicine, New York Presbyterian Hospital
    • North Carolina
      • Durham, North Carolina, Forente stater, 27708
        • Rekruttering
        • Duke University School of Medicine, Division of Hematology
  • Frankrike
      • Bron, Frankrike
        • Rekruttering
        • Centre de Référence de l'Hémophilie Unité d'Hémostase Clinique Hôpital Cardiologique Louis Pradel
      • Reims, Frankrike
        • Rekruttering
        • University Hospital of Reims
      • Rouen, Frankrike
        • Rekruttering
        • Centre Hospitalier Universitaire de Rouen (CHU de Rouen) - Centre de Traitement des Maladies Hemorragiques (CRTH) (Centre d'Hemophiles)
  • Georgia
      • Tbilisi, Georgia
        • Rekruttering
        • Aversi Clinic
  • Israel
      • Petah Tikva, Israel
        • Rekruttering
        • Rabin Medical Centre, Institute of Haematology
      • Ramat Gan, Israel
        • Rekruttering
        • Sheba Medical Centre
  • Italia
      • Bergamo, Italia, 24127
        • Rekruttering
        • Unita Strutturale Complessa di Immunoematologia e Medicina Trasfusionale -Dipartimento Interaziendale di Medicina Trasfusionale ed Ematologia - ASST Papa Giovanni XXIII ematologia Piazza OMS, 1
      • Milan, Italia
        • Rekruttering
        • Universita degli Studi di Milano - IRCCS Ospedale Maggiore Policlinico - Centro Emofilia e Trombosi Angelo Bianchi Bonomi
      • Padua, Italia
        • Rekruttering
        • University of Padua Medical School
      • Roma, Italia
        • Rekruttering
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Romania
      • Craiova, Romania
        • Rekruttering
        • Emergency County Hospital Craiova
  • Serbia
      • Belgrade, Serbia
        • Rekruttering
        • Clinical Center of Serbia
  • Spania
      • Madrid, Spania, 28046
        • Rekruttering
        • Hospital Universitario La Paz
      • Murcia, Spania
        • Rekruttering
        • Hospital Universitario Morales Meseguer
      • Ourense, Spania, 32005
        • Rekruttering
        • Ourense University Hospital
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spania, 33011
        • Rekruttering
        • Central University Hospital of Asturias
  • Storbritannia
      • London, Storbritannia
        • Rekruttering
        • Royal-free Hospital-Katherine Dormandy Haemophilia and Thrombosis Centre
      • London, Storbritannia
        • Rekruttering
        • St. Thomas Hospital, Guy's and St. Thomas' NHS Foundation Trust
  • Tsjekkia
      • Nymburk, Tsjekkia
        • Rekruttering
        • Centre for Thrombosis and Haemaostasis Nemocnice
  • Tyskland
      • Berlin, Tyskland
        • Rekruttering
        • Vivantes Klinikum Friedrichshain Klinik für Angiologie Hämostaseologie
      • Bonn, Tyskland
        • Rekruttering
        • UKB Bonn Institut für Experimentelle Hämatologie und Transfusionsmedizin
      • Duisburg, Tyskland
        • Rekruttering
        • Gerinnungszentrum Rhein-Ruhr
  • Ungarn
      • Debrecen, Ungarn
        • Rekruttering
        • University of Debrecen, Medical and Health Science Centre
  • Østerrike
      • Vienna, Østerrike
        • Rekruttering
        • Medizinische Universität Wien. Universitätsklinik für Innere Medizin Klinische Abteilung für Hämatologie und Hämostaseologie

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

12 år til 80 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Adult male or female patients ≥18 and ≤80 years of age. Solely in the US, 4 male or female patients between ≥12 and <17 years of age will be enrolled into the PK phase, and subsequently in the treatment phase, if applicable
  2. Documented congenital antithrombin deficiency, defined by plasma activity level of antithrombin ≤60% from medical history
  3. Personal or family history of TEs or TEEs (except for PK patients)
  4. For the Treatment Phase: either a) non-pregnant surgical patients scheduled for elective surgical procedure(s) known to be associated with a high risk for occurrence of TEs or TEEs, or b) pregnant patients of at least 27 weeks gestational age who are scheduled for caesarean section or delivery
  5. For female patients of childbearing potential entering the PK Phase who are not known to be pregnant, and for female surgical patients of childbearing potential entering the Treatment Phase for any procedure other than caesarean section or delivery, a negative urine pregnancy test at screening and at baseline
  6. Patient has provided informed consent

Exclusion Criteria:

  1. Requires emergency surgery or emergency caesarean section

  2. Has undergone surgery within the last 6 weeks

  3. History or suspicion of another hereditary thrombophilic disorder other than antithrombin deficiency (e.g., activated protein C [APC] resistance/Factor V Leiden, Protein S or C deficiency, prothrombin gene mutation [G20210A], or acquired [lupus anticoagulant] thrombophilic disorder)

  4. Malignancies, renal failure (patients on renal replacement therapy), or severe liver disease (aspartate aminotransferase [ASAT] >5 times the upper limit of normal)

  5. Body mass index >40 kg/m2 (for non-pregnant patients, only)

  6. Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ

  7. History of anaphylactic reaction(s) to blood or blood components

  8. Refusal to receive transfusion of blood-derived products

  9. Administration of any antithrombin concentrate or antithrombin-containing blood product within 14 days of either of the two phases of the study

  10. Prior diagnosis of heparin-induced thrombocytopenia

  11. TE or TEE within the last 6 months

  12. Female patients who are nursing at the time of screening*

  13. Have participated in another investigational study within the last 30 days

  14. Persons dependent on the sponsor, the investigator or the centre of investigation

  15. Persons placed in an institution by administrative or judicial order

    • criterion does not include female patients who plan to breastfeed after giving birth

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Atenativ treatment

During the PK phase, patients will receive a 60 IU/kg Atenativ as a single intravenous infusion for PK analysis.

During the treatment phase, patients will receive a single intravenous loading dose followed by maintenance doses administered every 24 hours for approximately 2-7 days for surgical patients and approximately 5 days for parturients
Legemiddel: Atenativ

Antithrombin concentrate

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Thrombotic event incidence
Tidsramme: Up to day 30 post treatment initiation

The primary objective of this study is to assess the incidence of the composite of TEs and TEEs in patients with congenital antithrombin deficiency under cover of Atenativ for surgical procedures or parturition
Up to day 30 post treatment initiation

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Single dose Pharmacokinetics of Atenativ: Area under the curve (AUCnorm(0-∞))
Tidsramme: Up to day 14 post PK infusion

Assess the area under the curve (AUCnorm(0-∞)) of Atenativ in patients with congenital antithrombin deficiency
Up to day 14 post PK infusion
Single dose Pharmacokinetics of Atenativ: Maximum plasma concentration (Cmax)
Tidsramme: Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion

Assess the maximum plasma concentration (Cmax) after a single dose of Atenativ in patients with congenital antithrombin deficiency
Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion
Single dose Pharmacokinetics of Atenativ: Half-life (t1/2)
Tidsramme: Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion

Assess the half-life (t1/2) after a single dose of Atenativ in patients with congenital antithrombin deficiency
Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion
Single dose Pharmacokinetics of Atenativ: Mean residence time (MRT)
Tidsramme: Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion

Assess the mean residence time (MRT) after a single dose of Atenativ in patients with congenital antithrombin deficiency
Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion
Single dose Pharmacokinetics of Atenativ: Clearance (CL)
Tidsramme: Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion

Assess the clearance (CL) after a single dose of Atenativ in patients with congenital antithrombin deficiency
Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion
Single dose Pharmacokinetics of Atenativ: Incremental in vivo recovery (IVR)
Tidsramme: Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion

Assess the Incremental in vivo recovery after a single dose of Atenativ in patients with congenital antithrombin deficiency
Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion
Single dose Pharmacokinetics of Atenativ: Volume of distribution at steady state (Vss)
Tidsramme: Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion

Assess the volume of distribution at steady state (Vss) after a single dose of Atenativ in patients with congenital antithrombin deficiency
Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion
Single dose Pharmacokinetics of Atenativ: Maximum Plasma Concentration (Tmax)
Tidsramme: Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion

Assess the time to reach Maximum Plasma Concentration (Tmax) after a single dose of Atenativ in patients with congenital antithrombin deficiency
Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion
10. Coagulation parameters: Activated partial thromboplastin time [aPTT]
Tidsramme: Up to day 7 post treatment initiation

Assess activated partial thromboplastin time [aPTT] in patients with congenital antithrombin deficiency undergoing surgical procedures or parturition
Up to day 7 post treatment initiation
Coagulation parameters: Prothrombin time [PT]
Tidsramme: Up to day 7 post treatment initiation

Assess prothrombin time [PT] in patients with congenital antithrombin deficiency undergoing surgical procedures or parturition
Up to day 7 post treatment initiation
Coagulation parameters: International normalised ratio [INR]
Tidsramme: Up to day 7 post treatment initiation

Assess international normalised ratio [INR] in patients with congenital antithrombin deficiency undergoing surgical procedures or parturition
Up to day 7 post treatment initiation
Coagulation parameters: Fibrinogen level
Tidsramme: Up to day 7 post treatment initiation

Assess fibrinogen in patients with congenital antithrombin deficiency undergoing surgical procedures or parturition
Up to day 7 post treatment initiation
Safety and tolerability: Number of adverse events (AEs)
Tidsramme: Up to day 30 post treatment initiation

Number of adverse events (AEs) following treatment with Atenativ in patients with congenital antithrombin deficiency
Up to day 30 post treatment initiation

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Octapharma

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)

1. juli 2022

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

18. mai 2021

Først innsendt som oppfylte QC-kriteriene

4. juni 2021

Først lagt ut (Faktiske)

8. juni 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ATN-106

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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