A Phase 1 interventional study of Ticagrelor in Sickle Cell Disease, sponsored by AstraZeneca. Completed at 8 sites in 6 countries. Open to participants aged 1 Day to 23 Months. Per ClinicalTrials.gov, last updated 2021-05-10.
Sponsored by AstraZeneca · Phase 1, Interventional, and Other
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Among 25 studies in Anemia, Sickle Cell with a site in Kenya — 5 open to participants now, 9 under way, 6 of them phase 3. Anemia, Sickle Cell · Kenya.
Among the 25 studies in Anemia, Sickle Cell with a site in Kenya, this one is the 25th largest by enrollment, is one of 3 that started in 2018, is one of 2 in phase 1, and was the 6th registered.
1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.
Browse Anemia, Sickle Cell studies →5 of the 25 studies in Anemia, Sickle Cell with a site in Kenya are open now. Recruiting first, the newest first:
Novo Nordisk A/S · Sites in Kenya, United States, Australia and 18 more countries
Ages 12+
Novo Nordisk A/S · Sites in Kenya, United States, Canada and 14 more countries
Ages 2+
Novartis Pharmaceuticals · Sites in Kenya, United States, Brazil and 2 more countries
Ages 12–100
Forma Therapeutics, Inc. · Sites in Kenya, Canada, France and 4 more countries
Ages 6 mo–18 yrs
Pfizer · Sites in Kenya, United States, Brazil and 4 more countries
Ages 12+
A study can be open while its sites in Kenya have not opened yet or have stopped. Only those recruiting at a site in Kenya →
Of the 177 Anemia, Sickle Cell studies recruiting now, 64 (36%) set no upper age limit and 97 (55%) stop at 75 or younger; 127 take children under 18; 29 take healthy volunteers.
This study: 1 Day to 23 Months · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
25 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 10 · Phase 3 15
First in 2013; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 21 is below the median of 40 across 769 interventional studies indexed under Anemia, Sickle Cell.
Median enrollment 236 across the 25 interventional studies. Of the 16 that completed or were terminated, 12 (75%) have results posted.
This tab as a report to print or save as PDF → With an account.
23 of 25 have an industry lead sponsor. The 10 most frequent:
AstraZeneca is the lead sponsor of 3,502 studies on the registry; 273 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
AstraZeneca has 7 studies filed under Anemia, Sickle Cell — fewer than ten, so there is no comparison to draw.
2 of the studies in Anemia, Sickle Cell with a site in Kenya that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06612268Phase 3Novo Nordisk A/SA Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease | 2027-08-27 |
| NCT06171217Children's Hospital Medical Center, CincinnatiRealizing Effectiveness Across Continents With Hydroxyurea | 2027-10-04 |
Add all 2 to your calendar (.ics) → With an account.
Among the 25 studies in Anemia, Sickle Cell with a site in Kenya, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this Phase I study is to investigate the pharmacokinetic properties of ticagrelor in pediatric patients from 0 to less than 24 months with sickle cell disease.
Ticagrelor dose level adjustment will require a Protocol amendment and regulatory approval.
Study design This Phase I paediatric study (in patients aged 0 to \<24 months) with ticagrelor is planned to be a multi-centre, open-label, single dose study.
Primary Objective:
To determine the PK properties of ticagrelor after a single oral dose
Secondary Objectives:
To determine the PK properties of the active metabolite (AR-C124910XX) after a single oral dose To assess the acceptability and the palatability of a single oral dose of ticagrelor
Safety Objective:
To assess safety and tolerability of a single oral dose of ticagrelor
Duration of treatment At least 20 eligible patients will receive a single open label oral dose of ticagrelor on Day 1.
Statistical methods A population PK analysis approach will be used to determine the PK parameters of ticagrelor and its metabolite AR-C124910XX in paediatric patients aged 0 to \<24 months eg, CL/F (oral clearance) (only for ticagrelor) and AUC.
The PK will also be described by presenting the observed plasma concentrations of Ticagrelor and its active metabolite for all individuals, as well as corresponding descriptive statistics.
No statistical comparisons are planned for the primary or secondary objectives, which will be summarised descriptively
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single dose of ticagrelor based on age
Drug: Ticagrelor
Patients will receive a single dose of ticagrelor
Also known as: AR-C124910XX is an active metabolite of ticagrelor given orally in a single dose. It will be measured, but it won't be given directly to subjects.
Peak Plasma Concentration (Cmax) of Ticagrelor
This measure is obtained from observed plasma concentrations
Time frame: 1,2,4,6 hours post dose
Area under plasma concentration curve
This measure is obtained from the population PK analysis
Time frame: 1,2,4,6 hours post dose
CL/F (Oral clearance)
This measure is obtained from the population PK analysis.
Time frame: 1,2,4,6 hours post dose
Peak Plasma Concentration (Cmax) for active metabolite (AR-C124910XX)
Time frame: 1,2,4,6 hours post dose
Area under plasma concentration curve
Time frame: 1,2,4,6 hours post dose
Assessment of ticagrelor suspension for palatability
Questionnaire with one five-options question reflecting different degrees of patients willingness to swallow, from "swallowed without problem" to "vomited up medication".
Time frame: Day 1, single timepoint assessment
Ran from Mar 2018 to primary completion in May 2019, 13 months.
Of 28 industry-sponsored phase 1 interventional studies under Anemia, Sickle Cell, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's 13 months is below that.
Counting every sponsor, half of 58 studies reached it within 36 months; a quarter within 18 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ticagrelor