Cangrelor Neonatal PK/PD and Safety Study
Study Identifier:
MDCO-CAN-15-01
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Thrombosis
Study Drug
- Drug: Cangrelor
Date
Jan 2017 - Aug 2019
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 1 Day - 28 Days
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- 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
Healthy Volunteers
No
Protocol Summary
The purpose of this study is to assess the PK/PD and safety profile of cangrelor in neonatal participants at risk of thrombosis.
Study Locations
Location
Status
Location
Columbia University Medical Center
New York, New York, United States, 10032
Status
N/A
Location
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Status
N/A