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

Recruiting now · Phase 3

Conditions studied: Congenital Antithrombin Deficiency

In brief

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.

Key facts

Study ID

NCT04918173

Run by

Octapharma

People needed

38

Starts

2022-07-01

Expected to finish

2026-12-01

Last updated by the study team

2026-06-03

Who can join

Age: 12 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Documented congenital antithrombin deficiency, defined by plasma activity level of antithrombin ≤60% from medical history
• Personal or family history of TEs or TEEs (except for PK patients)
• 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
• 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
• Patient has provided informed consent

You may not qualify if…

• Requires emergency surgery or emergency caesarean section
• Has undergone surgery within the last 6 weeks
• 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)
• Malignancies, renal failure (patients on renal replacement therapy), or severe liver disease (aspartate aminotransferase [ASAT] >5 times the upper limit of normal)
• Body mass index >40 kg/m2 (for non-pregnant patients, only)
• Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ
• History of anaphylactic reaction(s) to blood or blood components
• Refusal to receive transfusion of blood-derived products
• Administration of any antithrombin concentrate or antithrombin-containing blood product within 14 days of either of the two phases of the study
• Prior diagnosis of heparin-induced thrombocytopenia
• TE or TEE within the last 6 months
• Female patients who are nursing at the time of screening*
• Have participated in another investigational study within the last 30 days
• Persons dependent on the sponsor, the investigator or the centre of investigation
• Persons placed in an institution by administrative or judicial order
• criterion does not include female patients who plan to breastfeed after giving birth

Where it is running

• Georgetown University — Washington D.C., District of Columbia, United States (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• Bleeding and Clotting Disorders Institute — Peoria, Illinois, United States (enrolling)
• Weill Cornell Medicine — New York, New York, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• Yeolyan Hematology and Oncology Centre — Yerevan, Armenia (enrolling)
• Universitätsklinik für Innere Medizin Klinische Abteilung für Hämatologie und Hämostaseologie — Vienna, Austria (enrolling)
• Centre for Thrombosis and Haemaostasis — Nymburk, Czechia (enrolling)
• Centre de Référence de l'Hémophilie Unité d'Hémostase Clinique Hôpital Cardiologique Louis Pradel — Bron, France (enrolling)
• University Hospital of Reims — Reims, France (enrolling)
• Centre Hospitalier Universitaire de Rouen (CHU de Rouen) - Centre de Traitement des Maladies Hemorragiques (CRTH) (Centre d'Hemophiles) — Rouen, France (enrolling)
• Aversi Clinic — Tbilisi, Georgia (enrolling)
• Klinik fur Angiologie Hamostaseologie Haus 12 A Gerinnungssprechstunde — Berlin, Germany (enrolling)
• UKB Bonn Institut für Experimentelle Hämatologie und Transfusionsmedizin — Bonn, Germany (enrolling)
• Gerinnungszentrum Rhein-Ruhr — Duisburg, Germany (enrolling)
• University of Debrecen, Medical and Health Science Centre — Debrecen, Hungary (enrolling)
• Rabin Medical Centre, Institute of Haematology — Petah Tikva, Israel (enrolling)
• Sheba Medical Centre — Ramat Gan, Israel (enrolling)
• 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 (enrolling)
• Universita degli Studi di Milano - IRCCS Ospedale Maggiore Policlinico - Centro Emofilia e Trombosi Angelo Bianchi Bonomi — Milan, Italy (enrolling)
• University of Padua Medical School — Padua, Italy (enrolling)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (enrolling)
• Emergency County Hospital Craiova — Craiova, Romania (enrolling)
• Clinical Center of Serbia — Belgrade, Serbia (enrolling)
• Central University Hospital of Asturias — Oviedo, Principality of Asturias, Spain (enrolling)

Full record on ClinicalTrials.gov

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