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Hydroxyurea Optimisation in Sickle Cell Disease

Recruitingn/aAges 18 Years - anyAllOchuko Orherhe
NCT07543289 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The wide interindividual variability in clinical response to hydroxyurea therapy in the management of sickle cell disease has limited its use. These variabilities have been linked to differences in pharmacodynamics, pharmacokinetics, and pharmacogenetics. This study, therefore, aims to enhance understanding of these factors as they relate to hydroxyurea therapy, with the overall goal of developing a precision medicine algorithm. The study will be a prospective cohort pharmacokinetic study of 100 Nigerian patients with sickle cell disease, including current hydroxyurea users and naive patients. Pharmacodynamic markers will be collected to evaluate response. PopPK and PK-PD models will be developed in Monolix, exposure-response relationships will be analysed in R, and pregnancy, lactation, and paediatrics PBPK models will be developed in Simcyp or PK-SIM to inform dose optimisation. This

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with confirmed diagnosis of sickle cell disease (SCD) (e.g., HbSS, HbSC) and of Nigerian descent. * Patients currently on hydroxyurea therapy or hydroxyurea-naive patients who are willing to commence hydroxyurea therapy. * Patients whose genotypic profile for the major metabolising enzymes has been previously done e.g. CYP2D6. * Patients who consent to be part of the study Exclusion Criteria: * Patients with severe comorbidities that may significantly alter pharmacokinetics (e.g., advanced renal or hepatic failure) * Patients in acute crisis at the time of sampling. * Patients with documented poor adherence to other medications previously on. * Pregnant females and lactating mothers.
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What it tests

  • Hydroxyurea (HU)
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Where

1 site
Obafemi Awolowo University Teaching Hospital Complex
Ile-Ife, Nigeria
🤝 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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