NCT03763656

Pharmacokinetics of Oral Hydroxyurea Solution

A Prospective Open Label, Pharmacokinetic Study of an Oral Hydroxyurea Solution in Children With Sickle Cell Anemia.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Nova Laboratories Limited · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sickle Cell Disease
• Sickle-Cell; Hemoglobin Disease, Thalassemia
• Sickle Cell-beta-thalassemia
• Sickle Cell Hemoglobin C

Interventions

Type	Name	Description
DRUG	Oral Hydroxyurea (100 mg/mL) Solution	Participants received Oral Hydroxyurea 15 mg/kg once daily. Escalated by 5 mg/kg/day every 8-12 weeks until maximum tolerated dose achieved, up to a maximum 35 mg/kg/day.

Timeline

• Start date: 2019-01-03
• Primary completion: 2021-05-19
• Completion: 2021-12-29
• First posted: 2018-12-04
• Last updated: 2024-10-28
• Results posted: 2024-10-28

Locations

6 sites across 2 countries: Jamaica, United Kingdom