Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02482298 | A Study to Assess the Effect of Ticagrelor in Reducing the Number of Days With Pain in Patients With Sickle Cell Disease | PHASE2 | COMPLETED | 87 | — | — | Jul 9, 2015 | Nov 16, 2016 | Dec 19, 2018 | 20 | United States, Egypt +6 |
| NCT03492931 | PK Study of Ticagrelor in Children Aged Less Than 24 Months, With Sickle Cell Disease (HESTIA4) | PHASE1 | COMPLETED | 21 | — | — | Mar 28, 2018 | May 7, 2019 | May 10, 2021 | 8 | Belgium, Italy +4 |
To investigate the efficacy of 2 different doses of ticagrelor versus placebo in reducing the number of days with pain due to sickle cell disease.
This measure is obtained from observed plasma concentrations
This measure is obtained from the population PK analysis
This measure is obtained from the population PK analysis.
| Arm | Type | Description |
|---|---|---|
| Dose A | EXPERIMENTAL | - |
| Dose B | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Treatment arm | EXPERIMENTAL | Single dose of ticagrelor based on age |
| Name | Type | Description |
|---|---|---|
| Ticagrelor | DRUG | Two arms: 1) 10 mg ticagrelor + 45 mg ticagrelor placebo or 2) 45 mg ticagrelor + 10 mg ticagrelor placebo. Drugs taken orally, twice a day (morning and evening, at least 12 hours apart) from randomization until the end of treatment. |
| Placebo | DRUG | 10 mg ticagrelor placebo + 45 mg ticagrelor placebo. Drugs taken orally, twice a day (morning and evening at least 12 hours apart) from randomization until the end of treatment |
Inclusion Criteria: * Confirmed medical history or diagnosis of homozygous sickle cell (HbSS) or sickle beta-zero-thalassaemia (HbS/β0) by HPLC * If treated with hydroxyurea, the dose must have been stable for 3 months Exclusion Criteria: * History of transient ischaemic attack or clinically over...