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Hydroxyurea PK in Pediatric Sickle Cell Disease (HOPE18)
NCT03825341Phase 2
Key facts
- Status
- Terminated
- Start
- Jun 2019
- Primary completion
- Jan 2022
- Countries
- 1
- Sponsor
- St. Jude Children's Research Hospital
- Modality
- Small Molecules
- Drugs
- hydroxyurea
- Conditions
- sickle cell disease (SCD)
01
Overview
Phase 2, randomised, open-label trial of hydroxyurea in sickle cell disease (SCD) (2 arms), sponsored by St. Jude Children's Research Hospital. Primary endpoints: Maximum Concentration Observed After Dosing at 1 day, Time of Maximum Observed Concentration at 1 day and 6 more. Started Jun 2019; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Arm 1 Liquid Hydroxyurea
Infants (9mo-2yr) receiving single dose of liquid HU
Arm 2 Crossover
Children (2-18yr) receiving Sprinkles and Capsules in crossover fashion
03
Who it enrols
Infants (9mo-2yr) and children (2-18yr) with HbSS or HbS-beta0 thalassemia, normal organ function, and no chronic transfusion therapy.
04
Endpoints
Primary
Maximum Concentration Observed After Dosing
Time of Maximum Observed Concentration
Area Under the Curve to the Last Measurable Concentration
Area Under the Curve to Infinity
Mean Residence Time
Secondary
Maximum Concentration Observed After Dosing
Time of Maximum Observed Concentration
Area Under the Curve to the Last Measurable Concentration
Area Under the Curve to Infinity
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