CTRI/2018/09/015649招募中1 期
A Phase 1, Open-label, Single-dose, Non-randomized Study to Evaluate Pharmacokinetics (PK) andPharmacodynamics (PD) of Edoxaban in Pediatric Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients who are at risk of thromboembolic events (e.g., patients with
- •thrombophilia, congenital heart disease, presence of a central venous
- •- Patients who are completing their standard-of-care anticoagulatory therapy.Note that minimum time from the last dose of the standard of careanticoagulant medication and the dose of the study drug should be at least6 hours for unfractionated heparin; 24 hours for vitamin K antagonists(e.g., warfarin) and any other anticoagulants. Note: Before edoxabantreatment, all patients who receive vitamin K antagonists must have aninternational normalization ratio (INR) value < 2.0 within 48 hours prior tothe treatment. If the patientâ??s INR is > 2.0, the patientâ??s INR should be monitored until it is < 2.0;
- •-Patients with cardiac conditions who may require anticoagulation therapy; or
- •-Patients with sickle cell disease who may require anticoagulation therapy.
- •1. Able to provide written informed assents (patients, when applicable) and ICFs (signed by parent/legal guardian) prior to participating in the study
- •2. Male or female patients 0 to <18 years of age on the day of dosing
- •3. Patients 2 to < 18 years of age must have a body mass index (BMI) between the 5th and 95th percentile based on the 2000 CDC Growth Charts (the maximum number of patients in each dose group that have a BMI between 85th and 95th percentile should not be more than 2 patients). Patients < 2 years of age must have a body weight between the 5th and 90th percentile based on the 2000 CDC Growth Charts
- •4. Female patients who have had menarche must test negative for pregnancy, as per local practice, at screening and check-in
- •5. Female patients who have had menarche and are sexually active must agree to use an effective contraception method, per local practice, for at least 30 days prior to edoxaban dose
- •6. Patients/Legal guardian(s) must agree to food and drug restrictions during the study
- •7. Patients must agree to abstain from the use of nonsteroidal anti-inflammatory drugs (such as ibuprofen), and antiplatelet and anticoagulant agents (except for low-dose aspirin) from 24 hours prior to edoxaban dose until after the last PK sample is collected
- •8. Patients on low-dose aspirin treatment (1 to 5 mg/kg/day, maximum of 100 mg/day) with an interruption of aspirin 24 hours prior to edoxaban dose and resuming 24 hours after edoxaban dose are permitted to participate in the study
- •per the Investigatorâ??s judgment that this does not place the patients at risk
- •9. Patients must agree to abstain from CYP3A4 inhibitors/inducers and P-gp inhibitors/inducers for 14 days prior to the edoxaban dose to until after the last PK sample is collected
- •10. Patients must agree to abstain from and/or legal guardians must agree not to give the patient cola, tea, coffee, chocolate, and other caffeinated drinks and food from 48 hours before dose administration through the end of the study
- •11. Other than signs and symptoms characteristic to their disease state, patients are to be in good health as determined by the absence of clinically significant deviations from normal, with respect to medical and surgical history, physical examination, vital signs, and laboratory reports, as deemed by the Investigator and the Sponsor, prior to enrollment
- •12. Patients must agree to abstain from and/or legal guardians must agree not to give the p
排除标准
- •1. History (within the last 6 months) of abnormal coagulation tests during screening, as defined by local laboratory reference ranges, which are not explained by anticoagulation therapy or temporary concomitant affections
- •2. Stroke where anticoagulant therapy is contraindicated
- •3. Patients with stage 2 hypertension defined as blood pressure confirmed > 99th percentile + 5 mmHg
- •4. Patients with renal function less than 50% of normal for age and size as determined by the National Kidney Disease Education Program version of the Schwartz formula
- •5. Actively bleeding or has a high risk of bleeding
- •5. Actively bleeding or has a high risk of bleeding
- •6. Has a currently active gastrointestinal ulceration or a known history of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding including bleeding from hemorrhoids) within the previous 6 months
- •7. Has known diabetic retinopathy
- •8. Has thrombocytopenia at screening ( < 20 Ã? 109/L)
- •9. Has had other unrelated clinically significant illness within 4 weeks prior to
- •Day 1, predose
- •10. Planned invasive procedures during or within 24 hours of study drug administration
- •11. Patient is receiving high-dose aspirin concurrently or within 2 weeks prior to dosing
- •12. Use of P-gp or CYP 3A4 inhibitors or inducers within 14 days prior to the edoxaban dose and expected to continue through the study duration
- •13. Patients with history of major bleeding and/or neurosurgery within 6 months of dosing
- •14. Patients with history of major trauma or surgery within the last month
- •15. Patients with known malabsorption disorders (e.g., cystic fibrosis or short bowel syndrome)
研究者
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