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Optimizing Hydroxyurea Dosage With Pharmakokinetic in Patients Suffering of Moderate to Severe Sickle Cell Anemia

RecruitingPhase 2, Phase 3Ages 6 Months - 18 YearsAllYves Pastore
NCT06761560 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this study is to evaluate if patients with sickle cell disease can achieve a maximum tolerate dose of hydroxuyrea (HU) over a period of 12 months faster with pharmacokinetic testing than the standard of care bloodwork follow-up. Pharmacokinetic test is used to evaluate the process by which drugs are absorbed, distributed in the body, localized in the tissues, and is excreted. Patient will be a randomized (coin toss method) into 2 groups. Group A will have an increase of their HU dosage with pharmacokinetic results and Group B will have an increase of their HU dosage following the standard of care bloodwork follow-up. Group C will include patient with sickle cell disease that has been taking HU for at least 12 months and will undergo a pharmacokinetic dosage to check the level of HU only one time.

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📋 Eligibility rules (as published)
Inclusion Criteria (Group A and B) : * Have had confirmed diagnosis of SCD at CHU Sainte-Justine biochemistry lab with hemoglobin electrophoresis. * Patients with SS, SBThal0. * Agree to take hydroxyurea for a period of 12 months * Be between age of 6months old and 18 years old. * Have consented for participation in the study. Inclusion Criteria (Group C) : * Have had confirmed diagnosis of SCD at CHU Sainte-Justine biochemistry lab with hemoglobin electrophoresis. * Patients with SS, SBThal0. * Have taken hydroxyurea for a period of at least 12 months, and have received HU at a stable dose and at MTD for at least 6 months. * Be between age of 6months old and 18 years old. * Have consented for participation in the study. Exclusion Criteria: * Patients with sickle cell genotype other than SS or SBThal0 (SC, SBThal+, SE or SD) * Patients on chronic transfusion program * Patients have received a blood transfusion in the last 4 weeks of study enrollment. * Have received a hematopoietic stem-cell transplantation * Creatinine \>2x normal for age * ALT\>2x normal for age * Sexually active females unwilling to comply with reliable method of birth control * Pregnancy * Conditions which in the opinion of the investigator, would compromise participation in the study will be excluded.
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What it tests

  • Pharmacokinetic based dosage change
  • Pharmacokinetic dosing
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Where

1 site
CHU Sainte-Justine
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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