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NCT03492931: HESTIA4

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

Completed Phase 1 Last updated 10 May 2021
What this trial tests

Phase 1 trial testing Ticagrelor in Sickle Cell Disease in 21 participants. Completed in 7 May 2019.

Timeline
28 March 2018
Primary endpoint
7 May 2019
7 May 2019

Quick facts

Lead sponsorAstraZeneca
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment21
Start date28 March 2018
Primary completion7 May 2019
Estimated completion7 May 2019
Sites8 locations across Italy, Belgium, United Kingdom, Lebanon, Kenya, Spain

Drugs / interventions tested

Conditions studied

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 1 Day to 23 Months, any sex, with Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. New insights into the pathophysiology and development of novel therapies for sickle cell disease.
    Moerdler S, Manwani D. · · 2018 · cited 24× · PMID 30504350 · DOI 10.1182/asheducation-2018.1.493
  2. Pharmacokinetics and safety of ticagrelor in infants and toddlers with sickle cell disease aged <24 months.
    Duniva Inusa BP, Inati A, Maes P, Githanga J, et al · · 2021 · cited 3× · PMID 33629819 · DOI 10.1002/pbc.28977

Verify or expand the search:

Other trials of Ticagrelor

Trials testing the same drug.

Other recruiting trials for Sickle Cell Disease

Currently open trials in the same condition.

Other AstraZeneca trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03492931.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing