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Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT04918173•Octapharma

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

12 - 80 years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

Locations (30)

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

Key Dates

Start Date

July 1, 2022

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2026

Last Updated

November 21, 2025

Enrollment

ESTIMATED participants

Conditions

Congenital Antithrombin Deficiency

Interventions

Atenativ

DRUG

Contacts

Sigurd Knaub

CONTACT

+41554512141 Sigurd.Knaub@octapharma.com