PK Study of Ticagrelor in Children Aged Less Than 24 Months, With Sickle Cell Disease (HESTIA4)

Summary

The purpose of this Phase I study is to investigate the pharmacokinetic properties of ticagrelor in pediatric patients from 0 to less than 24 months with sickle cell disease. Ticagrelor dose level adjustment will require a Protocol amendment and regulatory approval.

Timeline

Start

2018-03-28

Primary completion

2019-05-07

Completion

2019-05-07

Publications

• Duniva Inusa BP, Inati A, Maes P, Githanga J, Ogutu B, Abboud MR, Miano M, Cela E, Nduba V, Niazi M, Astrand M, Persson K, Berggren A, Carlson G. Pharmacokinetics and safety of ticagrelor in infants and toddlers with sickle cell disease aged <24 months. Pediatr Blood Cancer. 2021 May;68(5):e28977. doi: 10.1002/pbc.28977. Epub 2021 Feb 25.

Drugs

Indications