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

Octapharma

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 range: 12–80 years
Sex: All
Healthy volunteers: No

Detailed 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 fo…

Locations (30)

Georgetown University
Washington D.C., District of Columbia
University of Miami
Miami, Florida
Bleeding and Clotting Disorders Institute
Peoria, Illinois
Weill Cornell Medicine
New York, New York
Duke University
Durham, North Carolina
Yeolyan Hematology and Oncology Centre
Yerevan

Summary

Eligibility

Interventions

Locations (30)