A Multicentre, 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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2024
  • participants needed
    38
  • sponsor
    Octapharma
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Updated on 13 October 2022
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Summary

Assess the incidence of the composite of thrombotic events (TEs) and thromboembolic events (TEEs) in patients with congenital antithrombin deficiency under cover of Atenativ for surgical procedures or parturition.

Details
Condition Congenital Antithrombin Deficiency
Treatment Atenativ, Atenativ
Clinical Study IdentifierNCT04918173
SponsorOctapharma
Last Modified on13 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 the treatment phase, if needed
Level of antithrombin ≤60%
Personal or family history of TEs or TEEs
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

Exclusion Criteria

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, 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 other than the study medication 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
Have participated in another investigational study within the last 30 days
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