EUCTR2018-002562-40-GB进行中（未招募）1 期
A phase 1, open-label, single dose, non-randomized study to evaluate pharmacokinetics, pharmacodynamics, and safety of Betrixaban in pediatric patients. - Protocol 16-021 – Pediatric PK
Portola Pharma UK Ltd0 个研究点目标入组 33 人开始时间: 2019年10月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Pediatric patients in the following age categories: 12 to < 18 years of age and 2 to < 12 years of age. Part 1 of the study will enroll only adolescent patients 12 to < 18 years of age.
- •2. Patient is a pediatric subject who is assessed to be at risk for VTE but does not require immediate anticoagulant therapy, for example:
- •a. Has previous thrombosis and completed a course of anti-coagulant therapy, and is considered to have a risk for recurrence of VTE, or
- •b. Has any stable disease with a risk for arterial or venous thrombotic disorder, or
- •c. Has any functional CVAD (Central Venous Access Device) in the upper or lower venous system.
- •3. Patient must be able to have regular intake of a small amount of food (e.g., = 100 mL) and eat before taking study medication, when instructed.
- •4. Patient has normalized coagulation parameters (INR or PTT, as appropriate) within 7 days of study drug administration.
- •5. Patient is sexually abstinent or, if not sexually abstinent, agrees to use an approved method of contraception (if applicable).
- •6. Patient has adequate venous access to allow for blood sampling.
- •7. Patient has provided Assent and responsible parent or guardian has signed Informed Consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 33
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Patient received any dose of anticoagulant therapy within 7 days of Day 1.
- •2. Patient has active bleeding or has a comorbid disorder that places the patient at high risk for bleeding, including a positive fecal occult blood test or hematuria within 30 days prior to Day -1.
- •3. Patient has a comorbid disorder that places the patient at risk of death within 90 days of enrollment.
- •4. Patient has abnormal coagulation tests at baseline (within 3 days of Day -1).
- •5. Patient has had recent or planned invasive procedures, including lumbar puncture and removal of non-peripherally placed central lines during study.
- •6. Patient has hepatic disease associated with one or more of the following:
- •? Transaminase levels = 2.5 × Upper Limit of Normal (ULN) or bilirubin = 1.5 × ULN at baseline.
- •? Coagulopathy leading to a clinically relevant bleeding risk, or hepatic transaminase level of > 2 × ULN or total bilirubin > 2 × ULN with direct bilirubin > 20% of the total.
- •? Platelet count < 75 × 109/L or hemoglobin < 10.0 mg/dL.
- •? Hypertension.
- •7. Patient requires concomitant therapy with a strong P-gp inhibitor.
- •8. Patient has previous history of any non-traumatic bleeding event that was life threatening or required medical attention.
- •9. Patient had been administered thrombolytic therapy, or had undergone thrombectomy, or insertion of a caval filter to treat prior VTE.
- •10. Patient has known inherited or acquired bleeding diathesis or coagulopathy.
- •11. Patient has abnormal QTc interval on baseline ECG.
- •12. Patient will/has receive(d) a dose of any antiplatelet medication (including aspirin) within 14 days before study drug dosing. Planned or anticipated use of antiplatelet medication (including aspirin) in the first 24 hours following dosing shall exclude the patient.
- •13. Patient has malabsorption disorders (e.g., cystic fibrosis or short bowel syndrome).
- •14. Patient has an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min.
- •15. Patient is unable or reluctant to cooperate with the study procedures.
- •16. Patient has hypersensitivity to other Factor Xa inhibitors, or the components of the dosage form.
- •17. Patient has participated in a study with an investigational drug or medical device within 30 days prior to administration of betrixaban.
- •18. Patient is female and of childbearing potential and is either pregnant or breastfeeding a child.
- •19. Patient is sexually active and is not using medically accepted contraceptive method (if applicable).
- •20. Patient has positive Drugs of Abuse urine test at Screening (Part 1 subjects only) at Screening excluding medications prescribed by a physician during the current hospital stay.
研究者
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