Cangrelor Neonatal PK/PD and Safety Study

Phase 1

Completed

• Conditions: Partial Obstruction of Systemic to Pulmonary Artery Shunt; Complete Obstruction of Systemic to Pulmonary Artery Shunt
• Interventions: Drug: Cangrelor

• Registration Number: NCT02765633
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-06
• Study Start: 2017-01-03
• Primary Completion: 2019-08-31
• Study Completion: 2019-12-23
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cangrelor	Cangrelor	Cangrelor in up to four (4) dose cohorts consisting of a minimum of five participants in each cohort. One cohort of five participants will be enrolled at a time. Cohort 1 subjects will receive Cangrelor at 0.5 mcg/kg/min. Cohort 2 subjects will receive Cangrelor at 0.25 mcg/kg/min. Subsequent cohort dosing decisions are made at the completion of enrollment in each cohort.

Primary Outcome Measures

Name	Time	Method
Individual recovery of platelet function in neonates after cessation of the infusion	Up to 1 hour post infusion
Total plasma concentrations of cangrelor and its primary metabolite, AR C69712, during administration and after cessation of the infusion in neonates	During study drug infusion through 8 hours post infusion
Proportion of participants in each cohort who achieve ≥90% inhibition of final platelet aggregation as measured by light transmittance aggregometry (LTA) using 20 micromolar (µM) adenosine diphosphate (ADP) in platelet rich plasma	During study drug infusion through 1 hour post infusion
Assessment of the safety of cangrelor in neonatal participants by evaluating adverse events (AEs) and serious adverse events (SAEs)	from start of cangrelor infusion through 48 hours post cangrelor infusion

Trial Locations

Locations (2)

Columbia University Medical Center; 🇺🇸 New York, New York, United States

UPMC Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States