Status: Recruiting
Pharmacokinetics, Efficacy and Safety of Twice Daily Dosing Regimen of Hydroxycarbamide Dispersible Tablets in Children With Sickle Cell Disease
The purpose of this interventional, phase II, national, multicentric, non-randomised, open-label study is to evaluate the pharmacokinetics (PK), efficacy and safety of Hydroxycarbamide Paediatric dispersible tablets with a twice daily dosing regimen in children with Sickle Celle Disease between 9 months to 11 years of age. Participants will: * Take Hydroxycarbamide twice a day every day for 12 months * Visit the clinic at screening, baseline, 1, 3, 6, 9 and 12 months
Participants needed: 50
Trial details
Phase: Phase 2Age: 9-11Biological sex: AllType: InterventionalSponsor: TheraviaUpdated: Oct 1, 2026Locations: 7
Eligibility criteria
Written informed consent, signed and dated by both parents or by the legally acc... [+8]
Participation in any other clinical study for any other pharmaceutical product w... [+8]