clinical trial · NCT03763656
Pharmacokinetics of Oral Hydroxyurea Solution
Sickle Cell DiseaseSickle-Cell; Hemoglobin Disease, ThalassemiaSickle Cell-beta-thalassemiaSickle Cell Hemoglobin COral Hydroxyurea (100 mg/mL) Solution
brief summary
An open label, safety and pharmacokinetic study of oral hydroxyurea solution administered to children from 6 months to 17.99 years (i.e. to the day before 18th birthday), with a 12 to 15 month treatment period for each participant. The study treatment duration will be for 6 months at the maximum tolerated dose \[MTD\], which is usually reached by 6 months after initiation of treatment. For patients in whom time to MTD is longer than 6 months or not achieved at all, the maximum duration of study treatment will be 15 months.
started
Jan 3, 2019
primary completion
May 19, 2021
completion
Dec 29, 2021
last updated
Oct 28, 2024
official title
A Prospective Open Label, Pharmacokinetic Study of an Oral Hydroxyurea Solution in Children With Sickle Cell Anemia.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol