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

• Status: Completed
• Trial end date: 2017-02-27
• Target enrollment: 0
• Participant gender: All

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 in paediatric patients with sickle cell disease

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Ticagrelor

Criteria

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.