Pharmacokinetics, Efficacy and Safety of Twice Daily Dosing Regimen of Hydroxycarbamide Dispersible Tablets in Children With Sickle Cell Disease

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

January 21, 2025

Primary Completion Date

February 28, 2027

Study Completion Date

February 28, 2027

Conditions
Sickle Cell Disease
Interventions
DRUG

Hydroxycarbamid

"Hydroxycarbamide Paediatric dispersible tablets will be provided in the form of film-coated dispersible tablets containing 50 mg of hydroxycarbamide.~The IMP will be administered as half-strength twice daily, based on the body weight of the patient."

Trial Locations (6)

Unknown

RECRUITING

Centre Hospitalier Intercommunal Créteil, Créteil

RECRUITING

GHEF- Site de Marne-la-Vallée, Jossigny

RECRUITING

Hôpital Bicêtre, Le Kremlin-Bicêtre

ACTIVE_NOT_RECRUITING

Institut d'Hématologie et d'oncologie pédiatrique - IHOPe, Lyon

RECRUITING

Hôpital Necker-Enfants malades, Paris

RECRUITING

Centre hospitalier de Cayenne, Cayenne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Theravia

INDUSTRY

NCT06578507 - Pharmacokinetics, Efficacy and Safety of Twice Daily Dosing Regimen of Hydroxycarbamide Dispersible Tablets in Children With Sickle Cell Disease | Biotech Hunter | Biotech Hunter