2024-515830-34-00招募中3 期
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
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 17
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
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.
次要结局
- • 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)
- • 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
研究者
Vice President CR&D Haematology
Scientific
Octapharma AG
研究点 (17)
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