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Ticagrelor Dose 1a+ Dose 2a

Phase 2

Investigation of Platelet Aggregation in Paediatric Patients With Sickle Cell Disease | Small molecule | Hematology |AstraZeneca PLC|Last Updated: Dec 14, 2018

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

Ticagrelor Dose 1a+ Dose 2a · 1 trial · 1 indication

Phase 2 1
NCT02214121A Pharmacokinetic (PK) and Pharmacodynamic (PD) Dose-ranging Phase II Study of Ticagrelor in Paediatric Patients With Sickle Cell DiseaseInvestigation of Platelet Aggregation in Paediatric Patients With Sickle Cell Disease
COMPLETED46 Analytics
PHASE2COMPLETED
A Pharmacokinetic (PK) and Pharmacodynamic (PD) Dose-ranging Phase II Study of Ticagrelor in Paediatric Patients With Sickle Cell Disease
Investigation of Platelet Aggregation in Paediatric Patients With Sickle Cell Disease
NCT0221412146
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Study Endpoints

Primary Endpoints

P2Y12 Reaction Units (PRU) - Part A
PRU measurements are taken in conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7) and after repeated dosing at Visit 4 (Day 14). Up to 8 hours post-dose (6 hours following protocol amendment) Visit 2 and 3, and up to 2 hours Visit 4.
P2Y12 Reaction Units (PRU) - Part B
PRU measurements are taken after 4 weeks of double blind treatment at the end of Part B.
Maximum Plasma Concentration (Cmax) - Part A
PK measurements (up to 8 hours post-dose) are taken in conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7) and after repeated dosing at Visit 4 (Day 14).
Maximum Plasma Concentration (Cmax) - Part B
PK measurements (up to 4 hours post-dose) are taken after 4 weeks of double blind treatment at the end of Part B.
Area Under the Plasma Concentration Time Curve (AUC) - Part A
PK measurements (up to 8 hours post-dose) are taken in conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7) and after repeated dosing at Visit 4 (Day 14).

The PK parameter presented was derived using a model based analysis and not from a non-compartmental (NCA) analysis.

Area Under the Plasma Concentration Time Curve (AUC) - Part B
PK measurements (up to 4 hours post-dose) are taken after 4 weeks of double blind treatment at the end of Part B.

The PK parameter presented was derived using a model based analysis and not from a non-compartmental (NCA) analysis.

Secondary Endpoints

Assessment of Ticagrelor Concentration - Part A
In conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7), after repeated dosing at Visit 4 (Day 14). Up to 8h post-dose (6h following protocol amendment, no pre-dose) Visit 2 and 3, up to 2h Visit 4 (pre-dose, 1h added following amendment)
Assessment of Ticagrelor Concentration - Part B
PK measurements (up to 4 hours post-dose) are taken after 4 weeks of double blind treatment at the end of Part B.
Assessment of AR-C124910XX Concentration - Part A
In conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7), after repeated dosing at Visit 4 (Day 14). Up to 8h post-dose (6h following protocol amendment, no pre-dose) Visit 2 and 3, up to 2h Visit 4 (pre-dose, 1h added following amendment)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ticagrelor Dose 1a + Dose 2aOTHERPart A: Ticagrelor Dose 1a and ticagrelor Dose 2a single doses + 1 week repeated dosing Part B: Ticagrelor or placebo 4 weeks repeated dosing.
Ticagrelor Dose 1b + Dose 2bOTHERPart A: Ticagrelor Dose 1b and ticagrelor Dose 2b single doses + 1 week repeated dosing. Part B: Ticagrelor or placebo 4 weeks repeated dosing.

Interventions

NameTypeDescription
Ticagrelor Dose 1a + Dose 2aDRUGTicagrelor Dose 1a and ticagrelor Dose 2a single doses + 1 week ticagrelor repeated dosing followed by 4 weeks repeated dosing ticagrelor or placebo.
Ticagrelor Dose 1b + Dose 2bDRUGTicagrelor Dose 1b and ticagrelor Dose 2b single doses + 1 week ticagrelor repeted dosing followed by 4 weeks repeated dosing ticagrelor or placebo.
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Eligibility Criteria

Age Range2 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion criteria * Children aged ≥2 to \<18 years of age * Diagnosed with homozygous sickle cell (HbSS) or sickle beta-zero-thalassaemia (HbS/β0) Exclusion criteria * At risk for haemorrhagic or bradycardic events * Significant hepatic impairment * Renal failure requiring dialysis * Concomitant...

Countries:United StatesCanadaKenyaLebanonSouth AfricaUnited Kingdom
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Frequently asked questions about Ticagrelor Dose 1a+ Dose 2a

What is Ticagrelor Dose 1a+ Dose 2a used for in sickle cell disease?

Ticagrelor Dose 1a+ Dose 2a is an investigational small molecule being studied for the investigation of platelet aggregation in pediatric patients with sickle cell disease. It is being developed by AstraZeneca PLC (AZN) and is currently in Phase 2 clinical development.

What does Ticagrelor Dose 1a+ Dose 2a target?

Ticagrelor Dose 1a+ Dose 2a is a small molecule that targets platelet aggregation. It is being investigated for its effects on platelet function in pediatric patients with sickle cell disease, a condition where abnormal platelet activity may contribute to disease complications.

Who makes Ticagrelor Dose 1a+ Dose 2a?

Ticagrelor Dose 1a+ Dose 2a is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 2 clinical development for pediatric sickle cell disease.

What phase is Ticagrelor Dose 1a+ Dose 2a in?

Ticagrelor Dose 1a+ Dose 2a is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for its safety and efficacy in pediatric patients with sickle cell disease.

What clinical trials is Ticagrelor Dose 1a+ Dose 2a in?

Ticagrelor Dose 1a+ Dose 2a is associated with one completed Phase 2 clinical trial, NCT02214121. This was a randomized, double-blind, controlled study that enrolled 46 pediatric patients with sickle cell disease across the United States, Canada, Kenya, Lebanon, South Africa, and the United Kingdom.

Is Ticagrelor Dose 1a+ Dose 2a the same as ticagrelor?

Ticagrelor Dose 1a+ Dose 2a is a specific dose regimen of ticagrelor, a small molecule antiplatelet agent. In this context, it refers to the investigational use of ticagrelor at particular dose levels being studied in pediatric patients with sickle cell disease.