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Completed

NCT Number: NCT02765633

Cangrelor Neonatal PK/PD and Safety Study

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

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Key information

Conditions

Partial Obstruction of Systemic to Pulmonary Artery Shunt Complete Obstruction of Systemic to Pulmonary Artery Shunt

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Columbia University Medical Center, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females with congenital heart disease, and ranging in age from birth through 28 days of life
  • Postoperative neonatal cardiac participants with placement of systemic-to-pulmonary artery palliative shunts, right ventricle to pulmonary artery palliative shunts, or ductus arteriosus stents who are at risk of thrombotic events after repair for structural congenital heart disease.
  • Written informed consent from a parent/legal guardian
  • Life expectancy of at least 15 days at study entry

Participants will be excluded from the study if any of the following exclusion criteria apply:

  • History of intracerebral bleed (confirmed by a ultrasound (US) of the head prior to surgery), or cerebral arteriovenous malformation, or any prior bleed with neurological deficit
  • Gastrointestinal or urinary bleeding
  • Cerebrovascular accident or any cerebrovascular accident with a residual neurological deficit
  • Known congenital or acquired bleeding or clotting disorder
  • Weight less than 2.5 kilograms (kg)
  • Adjusted gestational age less than 37 weeks
  • Platelet count less than 100,000 cells/microliter (µL)
  • Chest and/or mediastinal tube blood output of greater than 3 milliliters (mL)/kg/hour (hr) at the time of cangrelor administration
  • Participants with evidence of severe hepatic or renal failure [aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than three times normal for age or total bilirubin greater than 20 milligrams (mg)/deciliter (dL); creatinine greater than 2 times the normal upper limit]
  • Known allergy to cangrelor or known sensitivity to any component of cangrelor
  • Any condition that in the investigator's opinion would constitute a contraindication to participation in the study or cause inability to comply with the study requirements
  • Participation in another investigational therapeutic drug or investigational therapeutic device trial within 30 days of starting study
  • Participants who have been receiving warfarin (Coumadin®) therapy

Treatment and study plan

cangrelor

Drug

Primary outcomes

  1. Total plasma concentrations of cangrelor and its primary metabolite, AR C69712, during administration and after cessation of the infusion in neonates

    Time frame: During study drug infusion through 8 hours post infusion

  2. 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

    Time frame: During study drug infusion through 1 hour post infusion

  3. Individual recovery of platelet function in neonates after cessation of the infusion

    Time frame: Up to 1 hour post infusion

  4. Assessment of the safety of cangrelor in neonatal participants by evaluating adverse events (AEs) and serious adverse events (SAEs)

    Time frame: from start of cangrelor infusion through 48 hours post cangrelor infusion

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 6, 2016
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.