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A Prospective, Open-Label, Single-Arm, Multi-Center Study To Assess The Pharmacokinetics/Pharmacodynamics (PK/PD) And Safety Of Different Cangrelor Doses In Neonatal Subjects At Risk Of Thrombosis

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Trial Profile

A Prospective, Open-Label, Single-Arm, Multi-Center Study To Assess The Pharmacokinetics/Pharmacodynamics (PK/PD) And Safety Of Different Cangrelor Doses In Neonatal Subjects At Risk Of Thrombosis

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 22 Jul 2022

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At a glance

  • Drugs Cangrelor (Primary)
  • Indications Coronary thrombosis
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Sponsors Chiesi USA

    • Most Recent Events

    • 17 Nov 2020 Results presented at the American Heart Association Scientific Sessions 2020
    • 20 Oct 2020 Primary endpoint (Proportion of participants in each cohort who achieve 90% inhibition of final platelet aggregation as measured by light transmittance aggregometry (LTA) using 20 micromolar (M) adenosine diphosphate (ADP) in platelet rich plasma) has been met according to the results published in the Journal of Thrombosis and Haemostasis
    • 20 Oct 2020 Results assessing pharmacokinetics (PK), pharmacodynamics (PD) and safety of cangrelor in neonates undergoing stage 1 palliation published in the Journal of Thrombosis and Haemostasis
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