A pharmacokinetic (PK) and pharmacodynamic (PD) dose-ranging Phase II study of ticagrelor followed by a 4 weeks extension phase in paediatric patients with sickle cell disease
- Conditions
- Investigation of platelet aggregation in paediatric patients with sickle cell diseaseMedDRA version: 18.1 Level: LLT Classification code 10040644 Term: Sickle cell disease System Organ Class: 100000004850Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
- Registration Number
- EUCTR2014-001006-18-GB
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 73
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method