Hydroxyurea Use in Sickle Cell Disease: Personalizing Dose in Nigerian Patients
Official title: Pharmacogenetics and Model-Informed Optimisation of Hydroxyurea Therapy in Sickle Cell Disease Patients of Nigerian Descent
Run by Obafemi Awolowo University · NCT07543289 · Data updated 2026-11-12
This observational study tests how genetic, pharmacokinetic, and pharmacodynamic differences affect hydroxyurea response in Nigerian people with sickle cell disease to help tailor dosing.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Obafemi Awolowo University Academic / other |
| Locations | 1 site (Ile-Ife, Osun State) |
| Status | Recruiting |
| Started | May 8, 2026 |
| Main results expected | April 30, 2027 |
| Study ends | October 2027 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07543289 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Nigerian individuals with diagnosed sickle cell disease who are already on hydroxyurea or are willing to start therapy, have known metabolic enzyme genotypes, and can consent to participation.
✕Probably not a fit
Patients with severe organ dysfunction, acute crisis at sampling, poor adherence history, or pregnancy/lactation are less likely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective cohort studies 100 Nigerian patients with sickle cell disease, including both current hydroxyurea users and those starting therapy. It will collect pharmacodynamic markers and develop population pharmacokinetic and pharmacokinetic-pharmacodynamic models to understand variability in response. The project will use Monolix for PK modeling and R for exposure–response analysis, with PBPK models in Simcyp or PK-SIM to inform dose optimization. The goal is to build a pharmacometric framework that links drug exposure, genetics, and clinical outcomes to support precision dosing of hydroxyurea.
Why it matters
Potential benefit: If successful, the study could enable more accurate hydroxyurea dosing to maximize benefit and minimize adverse effects in SCD patients.
How similar studies have gone: Similar pharmacometrics approaches have shown promise in optimizing drug dosing for other diseases, supporting the potential value of this work in SCD.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Obafemi Awolowo University Teaching Hospital Complex
Ile-Ife, Osun State, Nigeria Recruiting
Study contacts
- Study coordinator: Ochuko M. Orherhe, M.Phil.
- Email: oorherhe@oauife.edu.ng
- Phone: +2348051589453
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.