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

Launched by OCTAPHARMA · Jun 4, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called Atenativ in patients with a condition known as congenital antithrombin deficiency, especially during surgeries or childbirth. Patients with this condition have a lower level of antithrombin, which can increase the risk of blood clots. The trial aims to see if Atenativ can help reduce the chances of blood clots or other related complications during these procedures.

To participate in the trial, you need to be an adult between the ages of 18 and 80, or a younger patient aged 12 to 17 if you're in the U.S. You should have a low level of antithrombin and either a personal or family history of blood clots. Eligible participants will either be scheduled for high-risk surgeries or pregnant women nearing delivery. Participants will receive careful monitoring and support throughout the study. It’s important to note that certain conditions or recent medical history may prevent someone from joining, so discussing eligibility with a healthcare provider is essential.

Gender

ALL

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 \<17 years of age will be enrolled into the PK phase, and the treatment phase, if needed
• • 2. Level of antithrombin ≤60%
• • 3. Personal or family history of TEs or TEEs
• • 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, 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 other than the study medication 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
• • 13. Have participated in another investigational study within the last 30 days