Clinical Trial Results:
A Multi-centre, Phase I, Open-label, Single-dose Study to Investigate Pharmacokinetics (PK) of Ticagrelor in Infants and Toddlers, Aged 0 to less than 24 Months, with Sickle Cell Disease (HESTIA4)
Summary
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EudraCT number |
2017-003641-14 |
Trial protocol |
BE ES GB IT |
Global end of trial date |
07 May 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Nov 2019
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First version publication date |
06 Nov 2019
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
D5136C00010
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03492931 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
AstraZeneca
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Sponsor organisation address |
950 Wind River Ln, Gaithersburg, MD, United States, 20878
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Public contact |
Global Clinical Lead, AstraZeneca, +1 3028851180, ClinicalTrialTransparency@astrazeneca.com
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Scientific contact |
Global Clinical Lead, AstraZeneca, +1 3028851180, ClinicalTrialTransparency@astrazeneca.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000480-PIP01-08 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
07 May 2019
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
07 May 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
D5136C00010 is part of a paediatric development programme and is the first study with ticagrelor in paediatric patients aged 0 months to <24 months with sickle cell disease (SCD) to characterise pharmacokinetic (PK) properties after single doses.
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Protection of trial subjects |
This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Council for Harmonisation/Good Clinical Practice, applicable regulatory requirements and the AstraZeneca policy on Bioethics.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
28 Mar 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 3
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Country: Number of subjects enrolled |
Italy: 1
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Country: Number of subjects enrolled |
Kenya: 7
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Country: Number of subjects enrolled |
Lebanon: 7
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Country: Number of subjects enrolled |
Spain: 1
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Country: Number of subjects enrolled |
United Kingdom: 2
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Worldwide total number of subjects |
21
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EEA total number of subjects |
7
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
21
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Paediatric patients aged 0 to <24 months with SCD were recruited to this Phase I open-label, single-dose study at 8 study centres in Belgium, Italy, Kenya, Lebanon, Spain and the United Kingdom. The first patient started in March 2018 and the last patient completed in May 2019. | ||||||||||||||||
Pre-assignment
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Screening details |
Patients were diagnosed with homozygous sickle cell anaemia or sickle beta-zero-thalassaemia and had a body weight of at least 5 kilograms (kg) at screening. Patients participating in this study were not withheld from any other standard of care treatments that may be used in SCD. | ||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Ticagrelor 0.1 mg/kg: <6 months old | ||||||||||||||||
Arm description |
Patients in the age group <6 months old received a single oral dose of 0.1 milligrams per kg (mg/kg) ticagrelor. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Ticagrelor
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Investigational medicinal product code |
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Other name |
BRILINTA™
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Pharmaceutical forms |
Granules for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
A single oral 0.1 mg/kg dose of ticagrelor. Before administration, ticagrelor granules were constituted with 10 millilitres (mL) of purified water to form a homogenous suspension of 1 mg/mL ticagrelor.
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Arm title
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Ticagrelor 0.2 mg/kg: 6 to <12 months old | ||||||||||||||||
Arm description |
Patients in the age group 6 to <12 months old received a single oral dose of 0.2 mg/kg ticagrelor. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Ticagrelor
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Investigational medicinal product code |
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Other name |
BRILINTA™
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Pharmaceutical forms |
Granules for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
A single oral 0.2 mg/kg dose of ticagrelor. Before administration, ticagrelor granules were constituted with 10 mL of purified water to form a homogenous suspension of 1 mg/mL ticagrelor.
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Arm title
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Ticagrelor 0.2 mg/kg: 12 to <24 months old | ||||||||||||||||
Arm description |
Patients in the age group 12 to <24 months old received a single oral dose of 0.2 mg/kg ticagrelor. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Ticagrelor
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Investigational medicinal product code |
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Other name |
BRILINTA™
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Pharmaceutical forms |
Granules for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
A single oral 0.2 mg/kg dose of ticagrelor. Before administration, ticagrelor granules were constituted with 10 mL of purified water to form a homogenous suspension of 1 mg/mL ticagrelor.
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Baseline characteristics reporting groups
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Reporting group title |
Ticagrelor 0.1 mg/kg: <6 months old
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Reporting group description |
Patients in the age group <6 months old received a single oral dose of 0.1 milligrams per kg (mg/kg) ticagrelor. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ticagrelor 0.2 mg/kg: 6 to <12 months old
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Reporting group description |
Patients in the age group 6 to <12 months old received a single oral dose of 0.2 mg/kg ticagrelor. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ticagrelor 0.2 mg/kg: 12 to <24 months old
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Reporting group description |
Patients in the age group 12 to <24 months old received a single oral dose of 0.2 mg/kg ticagrelor. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Ticagrelor 0.1 mg/kg: <6 months old
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Reporting group description |
Patients in the age group <6 months old received a single oral dose of 0.1 milligrams per kg (mg/kg) ticagrelor. | ||
Reporting group title |
Ticagrelor 0.2 mg/kg: 6 to <12 months old
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Reporting group description |
Patients in the age group 6 to <12 months old received a single oral dose of 0.2 mg/kg ticagrelor. | ||
Reporting group title |
Ticagrelor 0.2 mg/kg: 12 to <24 months old
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Reporting group description |
Patients in the age group 12 to <24 months old received a single oral dose of 0.2 mg/kg ticagrelor. | ||
Subject analysis set title |
Ticagrelor 0.2 mg/kg: 6 to <24 months old
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Patients in the age group 6 to <24 months old received a single oral dose of 0.2 mg/kg ticagrelor.
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Subject analysis set title |
All Patients
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Patients received single oral doses of 0.1 mg/kg ticagrelor (<6 months old) or 0.2 mg/kg ticagrelor (6 to <24 months old).
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End point title |
Ticagrelor Mean Observed Plasma Concentrations [1] [2] | ||||||||||||||||||||||||||||||||
End point description |
Blood samples were taken up to 6 hours post-dose so that the number and volume of blood samples were compliant with European Ethical Considerations in a Paediatric Population 2008. The geometric mean observed plasma concentration of ticagrelor is presented for each timepoint of sampling after patients had received a single oral dose of ticagrelor. Data is presented for each of the 2 doses of ticagrelor as well as for all patients. The lower limit of quantification (LLOQ) of ticagrelor was 1.00 nanograms per millilitre (ng/mL). Data is presented for the PK analysis set which included all patients who received at least 1 dose of ticagrelor and provided at least 1 post-dose analysable plasma sample without any important protocol deviations or events that would exclude the patient. '(n=x,y,z)' indicates the number of patients analysed at each timepoint.
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End point type |
Primary
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End point timeframe |
Blood samples were collected on Day 1 at 1, 2, 4 and 6 hours post-dose.
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical comparisons were carried out for this study. All endpoints were evaluated using standard summary descriptive statistics. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Data is presented for all patients in the baseline period, with data for patients in the arms 'Ticagrelor 0.2 mg/kg: 6 to <12 months old' and 'Ticagrelor 0.2 mg/kg: 12 to <24 months old' represented within the analysis set 'Ticagrelor 0.2 mg/kg: 6 to <24 months old'. |
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Notes [3] - '9999999' indicates the data was not calculated due to the sample size. |
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No statistical analyses for this end point |
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End point title |
Ticagrelor Maximum Observed Plasma Concentrations (Cmax) [4] [5] | ||||||||||||||||
End point description |
Blood samples were taken up to 6 hours post-dose so that the number and volume of blood samples were compliant with European Ethical Considerations in a Paediatric Population 2008. The geometric mean Cmax for ticagrelor is presented for each of the 2 doses of ticagrelor and for all patients. Data is presented for the PK analysis set which included all patients who received at least 1 dose of ticagrelor and provided at least 1 post-dose analysable plasma sample without any important protocol deviations or events that would exclude the patient.
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End point type |
Primary
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End point timeframe |
Blood samples were collected on Day 1 at 1, 2, 4 and 6 hours post-dose.
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Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical comparisons were carried out for this study. All endpoints were evaluated using standard summary descriptive statistics. [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Data is presented for all patients in the baseline period, with data for patients in the arms ‘Ticagrelor 0.2 mg/kg: 6 to <12 months old’ and ‘Ticagrelor 0.2 mg/kg: 12 to <24 months old’ represented within the analysis set ‘Ticagrelor 0.2 mg/kg: 6 to <24 months old’. |
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No statistical analyses for this end point |
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End point title |
Ticagrelor Area Under the Plasma Concentration-Time Curve from Zero to 6 Hours (AUC[0-6]) [6] [7] | ||||||||||||||||
End point description |
Blood samples were taken up to 6 hours post-dose so that the number and volume of blood samples were compliant with European Ethical Considerations in a Paediatric Population 2008. The geometric mean AUC(0-6) for ticagrelor is presented for each of the 2 doses of ticagrelor and for all patients. Data is presented for the PK analysis set which included all patients who received at least 1 dose of ticagrelor and provided at least 1 post-dose analysable plasma sample without any important protocol deviations or events that would exclude the patient.
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End point type |
Primary
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End point timeframe |
Blood samples were collected on Day 1 at 1, 2, 4 and 6 hours post-dose.
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Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical comparisons were carried out for this study. All endpoints were evaluated using standard summary descriptive statistics. [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Data is presented for all patients in the baseline period, with data for patients in the arms ‘Ticagrelor 0.2 mg/kg: 6 to <12 months old’ and ‘Ticagrelor 0.2 mg/kg: 12 to <24 months old’ represented within the analysis set ‘Ticagrelor 0.2 mg/kg: 6 to <24 months old’. |
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No statistical analyses for this end point |
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End point title |
Active Metabolite (AR-C124910XX) Mean Observed Plasma Concentrations [8] | ||||||||||||||||||||||||||||||||
End point description |
Blood samples were taken up to 6 hours post-dose so that the number and volume of blood samples were compliant with
European Ethical Considerations in a Paediatric Population 2008. The geometric mean observed plasma concentration of AR-C124910XX is presented for each timepoint of sampling after patients had received a single oral dose of ticagrelor. Data is presented for each of the 2 doses of ticagrelor as well as for all patients. The LLOQ of AR-C124910XX was 2.50 ng/mL. Data is presented for the PK analysis set which included all patients who received at least 1 dose of ticagrelor and provided at least 1 post-dose analysable plasma sample
without any important protocol deviations or events that would exclude the patient. '(n=x,y,z)' indicates the number of patients analysed at each timepoint.
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End point type |
Secondary
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End point timeframe |
Blood samples were collected on Day 1 at 1, 2, 4 and 6 hours post-dose.
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Notes [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Data is presented for all patients in the baseline period, with data for patients in the arms ‘Ticagrelor 0.2 mg/kg: 6 to <12 months old’ and ‘Ticagrelor 0.2 mg/kg: 12 to <24 months old’ represented within the analysis set ‘Ticagrelor 0.2 mg/kg: 6 to <24 months old’. |
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Notes [9] - '99999999' indicates the data was not calculated due to the sample size. |
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No statistical analyses for this end point |
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End point title |
Active Metabolite (AR-C124910XX) Cmax [10] | ||||||||||||||||
End point description |
Blood samples were taken up to 6 hours post-dose so that the number and volume of blood samples were compliant with European Ethical Considerations in a Paediatric Population 2008. The geometric mean Cmax for AR-C124910XX is presented for each of the 2 doses of ticagrelor and for all patients. Data is presented for the PK analysis set which included all patients who received at least 1 dose of ticagrelor and provided at least 1 post-dose analysable plasma sample without any important protocol deviations or events that would exclude the patient.
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End point type |
Secondary
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End point timeframe |
Blood samples were collected on Day 1 at 1, 2, 4 and 6 hours post-dose.
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Notes [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Data is presented for all patients in the baseline period, with data for patients in the arms ‘Ticagrelor 0.2 mg/kg: 6 to <12 months old’ and ‘Ticagrelor 0.2 mg/kg: 12 to <24 months old’ represented within the analysis set ‘Ticagrelor 0.2 mg/kg: 6 to <24 months old’. |
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No statistical analyses for this end point |
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End point title |
Active Metabolite (AR-C124910XX) AUC(0-6) [11] | ||||||||||||||||
End point description |
Blood samples were taken up to 6 hours post-dose so that the number and volume of blood samples were compliant with European Ethical Considerations in a Paediatric Population 2008. The geometric mean AUC(0-6) for AR-C124910XX is presented for each of the 2 doses of ticagrelor and for all patients. Data is presented for the PK analysis set which included all patients who received at least 1 dose of ticagrelor and provided at least 1 post-dose analysable plasma sample without any important protocol deviations or events that would exclude the patient.
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End point type |
Secondary
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End point timeframe |
Blood samples were collected on Day 1 at 1, 2, 4 and 6 hours post-dose.
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Notes [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Data is presented for all patients in the baseline period, with data for patients in the arms ‘Ticagrelor 0.2 mg/kg: 6 to <12 months old’ and ‘Ticagrelor 0.2 mg/kg: 12 to <24 months old’ represented within the analysis set ‘Ticagrelor 0.2 mg/kg: 6 to <24 months old’. |
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No statistical analyses for this end point |
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End point title |
Observer Assessment of Acceptability and Palatability of Ticagrelor | ||||||||||||||||||||||||||||||||||||||||
End point description |
An observer's assessment of the patient's behaviour was performed directly as the patient was administered the single dose of ticagrelor on Day 1. The patient's willingness to swallow was recorded as one of the following: swallowed without a problem, some resistance but did swallow, spat out some/all of medication, vomited up the medication. The patient's negative response to palatability was assessed and the following outcomes were recorded: turned head to reject intake of the medication, twisted face or mouth in an expression of displeasure or other negative response. Data is presented for the safety analysis set which included all patients who received at least 1 single dose of ticagrelor, and for whom any post-dose data was available.
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End point type |
Secondary
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End point timeframe |
Day 1 (directly after treatment administration)
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
On-treatment adverse events (AEs) were collected from Day 1 up to Day 8 (approximately 1 week).
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Adverse event reporting additional description |
AEs are presented for the safety analysis set which included all patients who received at least 1 single dose of ticagrelor, and for whom any post-dose data was available.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.1
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Reporting groups
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Reporting group title |
Ticagrelor 0.1 mg/kg: <6 months old
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Reporting group description |
Patients in the age group <6 months old received a single oral dose of 0.1 mg/kg ticagrelor. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ticagrelor 0.2 mg/kg: 12 to <24 months old
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Reporting group description |
Patients in the age group 12 to <24 months old received a single oral dose of 0.2 mg/kg ticagrelor. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ticagrelor 0.2 mg/kg: 6 to <12 months old
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Reporting group description |
Patients in the age group 6 to <12 months old received a single oral dose of 0.2 mg/kg ticagrelor. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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05 Jan 2018 |
- The synopsis (Investigational product, dosage and mode of administration) and sections of the protocol relating to the rationale for study design, doses, and control groups, and interim analysis were changed to declare that any dose adjustments would require a protocol amendment and regulatory approval. The prediction level of reduction in platelet reactivity unit text was amended. These updates reflected the Medicines and Healthcare products Regulatory Agency request. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
For the endpoint 'Ticagrelor Mean Plasma Concentrations', '9999999' indicates the data was not calculable for the sample size. |