← Back to all trials
Recruiting
NCT04918173
Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery
Conditions: Congenital Antithrombin Deficiency
Sex: All
Ages: 12 Years – 80 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 38
Sponsor: Octapharma
Location: Georgetown University Washington D.C. District of Columbia
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 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 \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
Source: ClinicalTrials.gov (NCT04918173). StuddyBuddy aggregates publicly available trial information.
