Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery
NCT ID: NCT04918173
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
38 participants
INTERVENTIONAL
2022-07-01
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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
Atenativ
Antithrombin concentrate
Interventions
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Atenativ
Antithrombin concentrate
Eligibility Criteria
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Inclusion Criteria
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
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
12 Years
80 Years
ALL
No
Sponsors
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Octapharma
INDUSTRY
Responsible Party
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Locations
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Georgetown University
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States
Weill Cornell Medicine
New York, New York, United States
Duke University
Durham, North Carolina, United States
Yeolyan Hematology and Oncology Centre
Yerevan, , Armenia
Universitätsklinik für Innere Medizin Klinische Abteilung für Hämatologie und Hämostaseologie
Vienna, , Austria
Centre for Thrombosis and Haemaostasis
Nymburk, , Czechia
Centre de Référence de l'Hémophilie Unité d'Hémostase Clinique Hôpital Cardiologique Louis Pradel
Bron, , France
University Hospital of Reims
Reims, , France
Centre Hospitalier Universitaire de Rouen (CHU de Rouen) - Centre de Traitement des Maladies Hemorragiques (CRTH) (Centre d'Hemophiles)
Rouen, , France
Aversi Clinic
Tbilisi, , Georgia
Klinik fur Angiologie Hamostaseologie Haus 12 A Gerinnungssprechstunde
Berlin, , Germany
UKB Bonn Institut für Experimentelle Hämatologie und Transfusionsmedizin
Bonn, , Germany
Gerinnungszentrum Rhein-Ruhr
Duisburg, , Germany
University of Debrecen, Medical and Health Science Centre
Debrecen, , Hungary
Rabin Medical Centre, Institute of Haematology
Petah Tikva, , Israel
Sheba Medical Centre
Ramat Gan, , Israel
Unita Strutturale Complessa di Immunoematologia e Medicina Trasfusionale -Dipartimento Interaziendale di Medicina Trasfusionale ed Ematologia - ASST Papa Giovanni XXIII ematologia Piazza OMS, 1
Bergamo, , Italy
Universita degli Studi di Milano - IRCCS Ospedale Maggiore Policlinico - Centro Emofilia e Trombosi Angelo Bianchi Bonomi
Milan, , Italy
University of Padua Medical School
Padua, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Emergency County Hospital Craiova
Craiova, , Romania
Clinical Center of Serbia
Belgrade, , Serbia
Central University Hospital of Asturias
Oviedo, Principality of Asturias, Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Morales Meseguer
Murcia, , Spain
Ourense University Hospital
Ourense, , Spain
Royal-free Hospital-Katherine Dormandy Haemophilia and Thrombosis Centre
London, , United Kingdom
St. Thomas Hospital
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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ATN-106
Identifier Type: -
Identifier Source: org_study_id
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