Cangrelor Neonatal PK/PD and Safety Study

Chiesi

Status and phase: Completed; Phase 1

Conditions: Complete Obstruction of Systemic to Pulmonary Artery Shunt; Partial Obstruction of Systemic to Pulmonary Artery Shunt

Treatments: Drug: Cangrelor

Study type: Interventional

Funder types: Industry

Identifiers

NCT02765633

2016-000134-22 (EudraCT Number)

MDCO-CAN-15-01

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

1. Males and females with congenital heart disease, and ranging in age from birth through 28 days of life
2. 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.
3. Written informed consent from a parent/legal guardian
4. 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:

1. 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
2. Gastrointestinal or urinary bleeding
3. Cerebrovascular accident or any cerebrovascular accident with a residual neurological deficit
4. Known congenital or acquired bleeding or clotting disorder
5. Weight less than 2.5 kilograms (kg)
6. Adjusted gestational age less than 37 weeks
7. Platelet count less than 100,000 cells/microliter (µL)
8. Chest and/or mediastinal tube blood output of greater than 3 milliliters (mL)/kg/hour (hr) at the time of cangrelor administration
9. 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]
10. Known allergy to cangrelor or known sensitivity to any component of cangrelor
11. 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
12. Participation in another investigational therapeutic drug or investigational therapeutic device trial within 30 days of starting study
13. Participants who have been receiving warfarin (Coumadin®) therapy

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Cangrelor

Experimental group

Description:

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.

Treatment:

Drug: Cangrelor