Optimizing Hydroxyurea Dosage With Pharmakokinetic in Patients Suffering of Moderate to Severe Sickle Cell Anemia

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

January 15, 2025

Primary Completion Date

November 25, 2027

Study Completion Date

November 25, 2027

Conditions
Sickle Cell Disease (SCD)
Interventions
DIAGNOSTIC_TEST

Pharmacokinetic based dosage change

This study will compare 2 groups of sickle cell patients that are receiving hydroxyurea. Group A will have an increase in their dosage based on the pharmacokinetic result over a period of 12 months and Group B will have an increase in their dosage based on the standard of care follow-up over a period of 12 months. The aim is to evaluate if the group A can reach MTD faster than than the Group B

DIAGNOSTIC_TEST

Pharmacokinetic dosing

Patient with sickle cell disease will undergo one pharmacokinetic test after taking 12 months of hydroxyurea to evaluate HU-AUC at that timepoint

Trial Locations (1)

H3T 1C5

CHU Sainte-Justine, Montreal

All Listed Sponsors
collaborator

St. Justine's Hospital

OTHER

lead

Yves Pastore

OTHER

NCT06761560 - Optimizing Hydroxyurea Dosage With Pharmakokinetic in Patients Suffering of Moderate to Severe Sickle Cell Anemia | Biotech Hunter | Biotech Hunter