EUCTR2017-003641-14-ES进行中（未招募）1 期
A Multi-centre, Phase I, Open-label, Single-dose Study to Investigate Pharmacokinetics (PK) of Ticagrelor in Infants and Toddlers, Aged 0 to less than 24 Months, with Sickle Cell Disease - HESTIA4
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
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
入选标准
- •1.Paediatric patients aged <24 months, diagnosed with homozygous sickle cell (HbSS) or sickle beta-zero-thalassemia (HbS/ß0), as confirmed by high performance liquid chromatography or haemoglobin electrophoresis.
- •2.Body weight =5 kg at the time of screening.
- •3.If treated with an anti-sickling agent such as hydroxyurea, the weight-adjusted dose must be stable for 3 months before screening/enrolment.
- •4.Provision of signed and dated written informed consent from parents/legal guardians prior to any study specific procedures not part of standard medical care.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of transient ischaemic attack or cerebrovascular event/accident (ischaemic or haemorrhagic), severe head trauma, intracranial haemorrhage, intracranial neoplasm, arteriovenous malformation, aneurysm, or proliferative retinopathy.
- •2. Significantly underdeveloped with regards to height, weight or head circumference for age, as judged by the Investigator.
- •3. Severe developmental delay (eg, cerebral palsy or mental retardation).
- •4. Receiving chronic treatment (>3 days/week) with non-steroidal anti-inflammatory drugs (NSAIDs).
- •5. Receiving chronic treatment with anticoagulants or antiplatelet drugs that cannot be discontinued.
- •6. Moderate or severe hepatic impairment, defined as laboratory values of alanine aminotransferase (ALT) >2 × upper limit of normal (ULN), total bilirubin >2 × ULN (unless judged by the Investigator to be caused by haemolysis), albumin <35 g/L and international normalised ratio (INR) >1.4, or symptoms of liver disease (eg, ascites).
- •7. Renal failure requiring dialysis.
- •8. Active pathological bleeding or increased risk of bleeding complications according to the Investigator.
- •9. Haemoglobin <6 g/dL from test performed at Screening (Visit 1).
- •10. Platelets <100 × 10E9/L from test performed at Screening (Visit 1).
- •11. Patient considered to be at risk of bradycardic events (eg, known sick sinus syndrome or second or third degree atrioventricular block).
- •12. Concomitant oral or intravenous therapy with moderate or strong CYP3A4 inhibitors, CYP3A4 substrates with narrow therapeutic indices, or strong CYP3A4 inducers, that have not been stopped at least 5 half-lives before dose administration.
- •13. Patient breastfed by mother who is under treatment of strong CYP3A4 inhibitors, as defined in Appendix E of the protocol.
- •14. Active untreated malaria. Patients with suspected malaria at Screening (Visit 1) will be tested.
- •15. Surgical procedure planned to occur during the study including 5 days after ticagrelor administration.
- •16. Known hypersensitivity or contraindication to ticagrelor.
- •17. Concern for the inability of the patient or parents to comply with study procedures and/or follow-up.
- •18. Any condition which, in the opinion of the Investigator, would make it unsafe or unsuitable for the patient to participate in this study.
- •19. Previously administered ticagrelor in the present study.
- •20. Participation in another clinical study with an investigational medicinal product (IMP) or device during the last 30 days preceding screening/enrolment.
- •21. Involvement of member of patient’s family in planning and/or conduct of the study (applies to both AstraZeneca personnel and personnel at study centre).
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