Status:
COMPLETED
A Pharmacokinetic (PK) and Pharmacodynamic (PD) Dose-ranging Phase II Study of Ticagrelor in Paediatric Patients With Sickle Cell Disease
Lead Sponsor:
AstraZeneca
Conditions:
Investigation of Platelet Aggregation in Paediatric Patients With Sickle Cell Disease
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
Brief Summary
The purpose of this Phase II dose-ranging study is to investigate pharmacokinetic (PK) and pharmacodynamic (PD) properties of various doses of ticagrelor followed by 4 weeks of twice-daily treatment i...
Detailed Description
This is a multicenter, open-label, dose-ranging study of ticagrelor followed by a double blind, placebo-controlled extension phase in paediatric patients with sickle cell disease (SCD). Part A: Patie...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Children aged ≥2 to \<18 years of age
- Diagnosed with homozygous sickle cell (HbSS) or sickle beta-zero-thalassaemia (HbS/β0)
- Exclusion criteria
- At risk for haemorrhagic or bradycardic events
- Significant hepatic impairment
- Renal failure requiring dialysis
- Concomitant oral or intravenous therapy with strong CYP3A4 (cytochrome) inhibitors, CYP3A4 substrates with narrow therapeutic indices, or strong CYP3A4 inducers.
- Surgical procedure planned to occur during the study.
- Patients who are currently pregnant or breastfeeding or planning to become pregnant during the study.
- Patients who have known hypersensitivity or contraindication to ticagrelor.
Exclusion
Key Trial Info
Start Date :
September 11 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2017
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT02214121
Start Date
September 11 2014
End Date
February 27 2017
Last Update
December 14 2018
Active Locations (18)
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1
Research Site
Orange, California, United States, 92868
2
Research Site
Chicago, Illinois, United States, 60612
3
Research Site
Detroit, Michigan, United States, 48201
4
Research Site
Hershey, Pennsylvania, United States, 17022