NCT04918173From ClinicalTrials.govRecruiting

Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery

A Multicenter, Prospective, Open-label, Uncontrolled Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery

Congenital Antithrombin Deficiency

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Octapharma
Enrolment target: 38
Started: 1 July 2022
Main results due: 1 December 2026
Study sites: 30
Registry updated: 28 September 2026

Can you take part?

Ages 12 years to 80 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(30)

Georgetown University Hospital
Washington D.C., District of Columbia, United States
Recruiting
University of Miami, Miller School of Medicine
Miami, Florida, United States
Recruiting
Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States
Recruiting
Weill Cornell Medicine, New York Presbyterian Hospital
New York, New York, United States
Recruiting
Duke University School of Medicine, Division of Hematology
Durham, North Carolina, United States
Recruiting
Yeolyan Hematology and Oncology Centre
Yerevan, Armenia
Recruiting
Medizinische Universität Wien. Universitätsklinik für Innere Medizin Klinische Abteilung für Hämatologie und Hämostaseologie
Vienna, Austria
Recruiting
Centre for Thrombosis and Haemaostasis Nemocnice
Nymburk, Czechia
Recruiting
Centre de Référence de l'Hémophilie Unité d'Hémostase Clinique Hôpital Cardiologique Louis Pradel
Bron, France
Recruiting
University Hospital of Reims
Reims, France
Recruiting
Centre Hospitalier Universitaire de Rouen (CHU de Rouen) - Centre de Traitement des Maladies Hemorragiques (CRTH) (Centre d'Hemophiles)
Rouen, France
Recruiting
Aversi Clinic
Tbilisi, Georgia
Recruiting
Vivantes Klinikum Friedrichshain Klinik für Angiologie Hämostaseologie
Berlin, Germany
Recruiting
UKB Bonn Institut für Experimentelle Hämatologie und Transfusionsmedizin
Bonn, Germany
Recruiting
Gerinnungszentrum Rhein-Ruhr
Duisburg, Germany
Recruiting
University of Debrecen, Medical and Health Science Centre
Debrecen, Hungary
Recruiting
Rabin Medical Centre, Institute of Haematology
Petah Tikva, Israel
Recruiting
Sheba Medical Centre
Ramat Gan, Israel
Recruiting
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
Recruiting
Universita degli Studi di Milano - IRCCS Ospedale Maggiore Policlinico - Centro Emofilia e Trombosi Angelo Bianchi Bonomi
Milan, Italy
Recruiting
University of Padua Medical School
Padua, Italy
Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Recruiting
Emergency County Hospital Craiova
Craiova, Romania
Recruiting
Clinical Center of Serbia
Belgrade, Serbia
Recruiting
Central University Hospital of Asturias
Oviedo, Principality of Asturias, Spain
Recruiting
Hospital Universitario La Paz
Madrid, Spain
Recruiting
Hospital Universitario Morales Meseguer
Murcia, Spain
Recruiting
Ourense University Hospital
Ourense, Spain
Recruiting
Royal-free Hospital-Katherine Dormandy Haemophilia and Thrombosis Centre
London, United Kingdom
Recruiting
St. Thomas Hospital, Guy's and St. Thomas' NHS Foundation Trust
London, United Kingdom
Recruiting

Showing 30 of 30 sites. 30 of the 30 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT04918173. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me