NCT05470270

Acceptability of a New Paediatric Formulation of Hydroxycarbamide in Children With Sickle Cell Disease.

An Open-label, Non-comparative, Multicentre Study to Evaluate the Acceptability of a New Paediatric Formulation of Hydroxycarbamide in Children With Sickle Cell Disease.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Theravia · Industry
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, interventional, phase II, open-label, multicentre, national, non-comparative study of a single administration of the new dispersible form of hydroxycarbamide at the usual dose in children with sickle cell disease who are already treated with the current form of hydroxycarbamide (Siklos® 100 mg and/or 1000 mg film-coated tablets).

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	Hydroxycarbamide	Single administration of the new dispersible form of hydroxycarbamide at the usual dose in children with sickle cell disease who are already treated with the current form of hydroxycarbamide.

Timeline

• Start date: 2022-07-08
• Primary completion: 2022-10-28
• Completion: 2022-10-28
• First posted: 2022-07-22
• Last updated: 2022-11-23

Locations

3 sites across 1 country: France