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Cangrelor Neonatal PK/PD and Safety Study

NCT02765633 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-02-15

No results posted yet for this study

Summary

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

Conditions

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

Interventions

DRUG

Cangrelor

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Thomas Diacovo, MD · Columbia University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-03
Primary Completion
2019-08-31
Completion
2019-12-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02765633 on ClinicalTrials.gov