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

What this Trial Is About

Researchers are evaluating the incidence of thrombotic events and thromboembolic events in patients with congenital antithrombin deficiency who receive Atenativ during surgery or childbirth. This phase 3, open-label study aims to assess the safety, efficacy, and pharmacokinetics of Atenativ in these patients. The study includes both surgical patients and pregnant patients undergoing delivery, addressing an important need in managing this rare blood disorder during high-risk procedures. Participants receive Atenativ, an antithrombin concentrate, in two phases. In the pharmacokinetics PK phase, a single intravenous dose of 60 IUkg is given to analyze how the drug behaves in the body. In the treatment phase, patients receive an initial intravenous loading dose followed by maintenance doses every 24 hours for about 2 to 7 days if undergoing surgery, or about 5 days if giving birth by caesarean section or delivery. Throughout the study, participants undergo regular blood tests to monitor coagulation parameters and drug levels up to 14 days after infusion, as well as safety monitoring for adverse events up to 30 days after treatment starts. Researchers closely track thrombotic event incidence up to 30 days post-treatment. Participants are involved in scheduled visits for drug administration, blood sampling, and clinical assessments to ensure thorough evaluation of Atenativs effects and safety during and after treatment.

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