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Study to Evaluate the Effect of Ticagrelor Versus Placebo in Reducing Vaso-Occlusive Crises Rate in Pediatric Patients With Sickle Cell Disease.

NCT04293172 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-07-15

No results posted yet for this study

Summary

The purpose of this study is to compare the effect of ticagrelor vs placebo for the reduction of Vaso-Occlusive crises in paediatric patients with Sickle Cell Disease

Conditions

Interventions

DRUG

Brilinta

Patients in the open-label Run-in period (patients aged 6 to \<24 months only) will receive ticagrelor 5 mg twice a day (body weight 6 to ≤9 kg), 10 mg twice a day (body weight \>9 to ≤12 kg) or 15 mg twice a day (body weight \>12 to ≤24 kg) for 14 days. The double-blind IP will be based on 5 weight bands: * 6 to ≤9 kg: ticagrelor 5 mg or matching placebo, twice a day * \>9 to ≤12 kg: ticagrelor 10 mg or matching placebo, twice a day * \>12 to ≤24 kg: ticagrelor 15 mg or matching placebo, twice a day * \>24 to ≤48 kg: ticagrelor 30 mg or matching placebo, twice a day * \>48 kg: ticagrelor 45 mg or matching placebo, twice a day

DRUG

Placebo

Patients in the open-label Run-in period (patients aged 6 to \<24 months only) will receive ticagrelor 5 mg twice a day (body weight 6 to ≤9 kg), 10 mg twice a day (body weight \>9 to ≤12 kg) or 15 mg twice a day (body weight \>12 to ≤24 kg) for 14 days. The double-blind IP will be based on 5 weight bands: * 6 to ≤9 kg: ticagrelor 5 mg or matching placebo, twice a day * \>9 to ≤12 kg: ticagrelor 10 mg or matching placebo, twice a day * \>12 to ≤24 kg: ticagrelor 15 mg or matching placebo, twice a day * \>24 to ≤48 kg: ticagrelor 30 mg or matching placebo, twice a day * \>48 kg: ticagrelor 45 mg or matching placebo, twice a day

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Anders Berggren, MD, PhD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2022-10-10
Completion
2022-10-10
FDA Drug
Yes

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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 NCT04293172 on ClinicalTrials.gov