Cangrelor Neonatal PK/PD and Safety Study

Phase 1 Completed 22 enrolled Chiesi Farmaceutici S.p.A.

NaSingle-groupOpen-labelPrevention

Summary

The purpose of this study is to assess the PK/PD and safety profile of cangrelor in neonatal participants at risk of thrombosis.

Timeline

Start: 2017-01-03
Primary completion: 2019-08-31
Completion: 2019-12-23

Outcome

Met primary endpoint

paper Whereas the primary PD endpoint was achieved at the higher dose (ie, reduction in maximal platelet aggregation by ≥90% in 60% of participants) PMID 33078501 ↗

Publications

Results Vargas D, Zhou H, Yu X, Diamond S, Yeh J, Allada V, Krishnamurthy G, Price M, Allen B, Alexander J, Schmidhofer J, Kreutzer J, Vincent J, Morell V, Bacha E, Diacovo T. Cangrelor PK/PD analysis in post-operative neonatal cardiac patients at risk for thrombosis. J Thromb Haemost. 2021 Jan;19(1):202-211. doi: 10.1111/jth.15141. Epub 2020 Nov 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cangrelor	Small molecule	0.25 ug/kg	Other
Subject	Cangrelor	Small molecule	0.5 ug/kg	Other