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PK Study of Ticagrelor in Children Aged Less Than 24 Months, With Sickle Cell Disease (HESTIA4)

NCT03492931 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-05-10

No results posted yet for this study

Summary

The purpose of this Phase I study is to investigate the pharmacokinetic properties of ticagrelor in pediatric patients from 0 to less than 24 months with sickle cell disease.

Ticagrelor dose level adjustment will require a Protocol amendment and regulatory approval.

Conditions

Interventions

DRUG

Ticagrelor

Patients will receive a single dose of ticagrelor

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
23 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-28
Primary Completion
2019-05-07
Completion
2019-05-07
FDA Drug
Yes

Countries

  • Belgium
  • Italy
  • Kenya
  • Lebanon
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03492931 on ClinicalTrials.gov