Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery
- Conditions
- Congenital antithrombin deficiency
- Registration Number
- 2024-515830-34-00
- Lead Sponsor
- Octapharma AG
- Brief Summary
The primary objective of this study is to assess the incidence of the composite of Thrombotic Events (TEs) and Thromboembolic Event (TEEs) in patients with congenital antithrombin deficiency under cover of Atenativ for surgical procedures or parturition.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 22
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
Documented congenital antithrombin deficiency, defined by plasma 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
Requires emergency surgery or emergency caesarean section
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
Persons dependent on the sponsor, the investigator or the center of investigation
Persons placed in an institution by administrative or judicial order
Prior diagnosis of heparin-induced thrombocytopenia
TE or TEE within the last 6 months
Female patients who are nursing at the time of screening
Have participated in another investigational study within the last 30 days
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 (patient on renal replacement therapy), 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of the composite of TEs and TEEs in patients with congenital antithrombin deficiency under cover of Atenativ for surgical procedures or parturition to 30 days post treatment initiation. Incidence of the composite of TEs and TEEs in patients with congenital antithrombin deficiency under cover of Atenativ for surgical procedures or parturition to 30 days post treatment initiation.
- Secondary Outcome Measures
Name Time Method • PK parameters: o Area under the curve (AUCnorm(0–∞)) o Maximum plasma concentration (Cmax) o Half-life (t1/2) o Mean residence time (MRT) o Clearance (CL) o Incremental in vivo recovery (IVR; peak concentration of antithrombin observed within the first hour after infusion) o Volume of distribution at steady state (Vss) o Time to reach Maximum Plasma Concentration (Tmax) • PK parameters: o Area under the curve (AUCnorm(0–∞)) o Maximum plasma concentration (Cmax) o Half-life (t1/2) o Mean residence time (MRT) o Clearance (CL) o Incremental in vivo recovery (IVR; peak concentration of antithrombin observed within the first hour after infusion) o Volume of distribution at steady state (Vss) o Time to reach Maximum Plasma Concentration (Tmax)
• Efficacy Parameters: o Antithrombin activity; o Coagulation parameters (activated partial thromboplastin time [aPTT], prothrombin time [PT], international normalised ratio [INR] and fibrinogen) • Efficacy Parameters: o Antithrombin activity; o Coagulation parameters (activated partial thromboplastin time [aPTT], prothrombin time [PT], international normalised ratio [INR] and fibrinogen)
• Safety Parameters: o Adverse events (AEs) and serious AEs (SAEs); o Length of hospital stay; o Vital signs (including systolic and diastolic blood pressure, pulse rate, body temperature, respiration rate, results of physical examination); o Standard haematological and clinical chemistry safety variables, as well as thrombogenicity markers including D-dimer, prothrombin fragment 1 + 2 (F1+2)*, and thrombin-antithrombin complex (TAT)* * if available from local laboratories • Safety Parameters: o Adverse events (AEs) and serious AEs (SAEs); o Length of hospital stay; o Vital signs (including systolic and diastolic blood pressure, pulse rate, body temperature, respiration rate, results of physical examination); o Standard haematological and clinical chemistry safety variables, as well as thrombogenicity markers including D-dimer, prothrombin fragment 1 + 2 (F1+2)*, and thrombin-antithrombin complex (TAT)* * if available from local laboratories
Trial Locations
- Locations (17)
University Of Debrecen
🇭🇺Debrecen, Hungary
Universitaetsklinikum Bonn AöR
🇩🇪Bonn, Germany
Gerinnungszentrum Rhein-Ruhr Aerztepartnerschaft Dr. med. Hannelore Rott Fachaerztin fuer Transfusionsmedizin Haemostaseologie Dr. med. Susan Halimeh Fachaerztin fuer Transfusionsmedizin Haemostaseologie Dr. med. Guenther Kappert Facharzt fuer Laboratoriumsmedizin Haemostaseologie
🇩🇪Duisburg, Germany
Sana Kliniken Duisburg GmbH
🇩🇪Duisburg, Germany
Vivantes Netzwerk fuer Gesundheit GmbH
🇩🇪Berlin, Germany
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Complejo Hospitalario Universitario De Ourense
🇪🇸Ourense, Spain
Hospital Universitario Central De Asturias
🇪🇸Oviedo, Spain
Centro Emofilia E Trombosi Angelo Bianchi Bonomi
🇮🇹Milan, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Scroll for more (7 remaining)University Of Debrecen🇭🇺Debrecen, HungaryZsolt Csaba OlahSite contact+36308397806zsolah@med.unideb.hu