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

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

June 30, 2020

Primary Completion Date

October 10, 2022

Study Completion Date

October 10, 2022

Conditions
Sickle Cell Disease
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

Lead Sponsor

All Listed Sponsors
collaborator

Iqvia Pty Ltd

INDUSTRY

lead

AstraZeneca

INDUSTRY