A Pharmacokinetic (PK) and Pharmacodynamic (PD) Dose-ranging Phase II Study of Ticagrelor in Paediatric Patients With Sickle Cell Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Investigation of Platelet Aggregation in Paediatric Patients With Sickle Cell Disease

In brief

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 in paediatric patients with sickle cell disease

Key facts

Study ID

NCT02214121

Run by

AstraZeneca

People needed

46

Starts

2014-09-11

Expected to finish

2017-02-27

Last updated by the study team

2018-12-14

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children aged ≥2 to <18 years of age
• Diagnosed with homozygous sickle cell (HbSS) or sickle beta-zero-thalassaemia (HbS/β0)

You may not qualify if…

• 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.

Where it is running

• Research Site — Orange, California, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Hershey, Pennsylvania, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Charleston, South Carolina, United States
• Research Site — Toronto, Ontario, Canada
• Research Site — Kisian, Kenya
• Research Site — Nairobi, Kenya
• Research Site — Beirut, Lebanon
• Research Site — Beirut, Lebanon
• Research Site — Tripoli, Lebanon
• Research Site — Parow, South Africa
• Research Site — Rondebosch, South Africa
• Research Site — Cardiff, United Kingdom
• Research Site — London, United Kingdom
• Research Site — London, United Kingdom
• Research Site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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