EUCTR2014-001006-18-IT进行中（未招募）1 期
Multicenter, open-label, randomised, pharmacokinetic (PK) and pharmacodynamic (PD) dose-ranging Phase II study of ticagrelor followed by a double-blind, randomised, parallel-group, placebo-controlled 4 weeks extension phase in paediatric patients with sickle cell disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 73
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.Children aged =2 to <18 years of age and body weight >16 kg diagnosed with homozygous sickle cell (HbSS) or sickle beta-zero-thalassaemia (HbS/ß0)
- •2.If treated with an anti-sickling agent such as hydroxyurea, the weight adjusted dose must be stable for 1 month before enrolment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •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.Previous history of transient ischemic attack (TIA) or clinically overt cerebrovascular accident (CVA) (ischemic or haemorrhagic), severe head trauma, intracranial haemorrhage, intracranial neoplasm, arteriovenous malformation, aneurysm, or proliferative retinopathy
- •2.Findings on TCD: Current or previous values for time averaged mean of the maximum velocity (TAMMV) that are Conditional or Abnormal*.
- •Conditional TAMMV values are =153 cm/sec using imaging TCD (TCDi) technique (corresponding to =170 cm/sec by the non-imaging technique). Both the middle cerebral artery and the internal carotid artery should be considered. Abnormal TAMMV values are =180 cm/sec using TCDi (corresponding to =200 cm/sec by the non-imaging technique) and are an indication for chronic transfusions because of a high stroke risk. Any other criteria that would locally be considered as TCD indications for chronic transfusion would also exclude the patient.
- •3.Undergoing treatment with chronic RBC transfusion therapy
- •4.Use of non-steroidal anti-inflammatory drugs (NSAIDs) >3 days per week
- •5.Receiving chronic treatment with anticoagulants or antiplatelet drugs that cannot be discontinued.
- •6.Moderate or severe hepatic impairment, defined as Child-Pugh Class B or C,or renal failure requiring dialysis
- •7.Active pathological bleeding or increased risk of bleeding complications according to Investigator
- •8.Risk of bradycardic events (known sick sinus syndrome or second or third degree atrioventricular block)
- •9.Concomitant oral or intravenous therapy with strong CYP3A4 inhibitors, CYP3A4 substrates with narrow therapeutic indices, or strong CYP3A4 inducers
- •10.Surgical procedure planned to occur during the study
- •11.Patients who are currently pregnant or breastfeeding, or planning to become pregnant during the study
- •12.Known hypersensitivity or contraindication to ticagrelor
研究者
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