NCT04918173招募中3 期
A Multicenter, 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Octapharma
- 入组人数
- 38
- 试验地点
- 55
- 主要终点
- Thrombotic event incidence
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 subsequently in the treatment phase, if applicable
- •Documented congenital antithrombin deficiency, defined by plasma activity level of antithrombin ≤60% from medical history
- •Personal or family history of TEs or TEEs (except for PK patients)
- •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
- •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 (patients 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)
- •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 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 at the time of screening*
- •Have participated in another investigational study within the last 30 days
- •Persons dependent on the sponsor, the investigator or the centre of investigation
- •Persons placed in an institution by administrative or judicial order
- •criterion does not include female patients who plan to breastfeed after giving birth
研究组 & 干预措施
Atenativ treatment
Experimental
During the PK phase, patients will receive a 60 IU/kg Atenativ as a single intravenous infusion for PK analysis.
During the treatment phase, patients will receive a single intravenous loading dose followed by maintenance doses administered every 24 hours for approximately 2-7 days for surgical patients and approximately 5 days for parturients
干预措施: Atenativ (Drug)
结局指标
主要结局
Thrombotic event incidence
时间窗: Up to day 30 post treatment initiation
The primary objective of this study is to assess the incidence of the composite of TEs and TEEs in patients with congenital antithrombin deficiency under cover of Atenativ for surgical procedures or parturition
次要结局
- Single dose Pharmacokinetics of Atenativ: Incremental in vivo recovery (IVR)(Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion)
- Single dose Pharmacokinetics of Atenativ: Area under the curve (AUCnorm(0-∞))(Up to day 14 post PK infusion)
- Single dose Pharmacokinetics of Atenativ: Half-life (t1/2)(Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion)
- Single dose Pharmacokinetics of Atenativ: Mean residence time (MRT)(Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion)
- Single dose Pharmacokinetics of Atenativ: Volume of distribution at steady state (Vss)(Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion)
- 10. Coagulation parameters: Activated partial thromboplastin time [aPTT](Up to day 7 post treatment initiation)
- Single dose Pharmacokinetics of Atenativ: Clearance (CL)(Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion)
- Single dose Pharmacokinetics of Atenativ: Maximum plasma concentration (Cmax)(Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion)
- Single dose Pharmacokinetics of Atenativ: Maximum Plasma Concentration (Tmax)(Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion)
- Coagulation parameters: Prothrombin time [PT](Up to day 7 post treatment initiation)
- Coagulation parameters: International normalised ratio [INR](Up to day 7 post treatment initiation)
- Coagulation parameters: Fibrinogen level(Up to day 7 post treatment initiation)
- Safety and tolerability: Number of adverse events (AEs)(Up to day 30 post treatment initiation)
研究者
研究点 (55)
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