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Pharmacokinetics of Oral Hydroxyurea Solution — HUPK  

Sickle Cell Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03763656
Study type Interventional
Source Nova Laboratories Limited
Contact
Status Completed
Phase Phase 2
Start date November 20, 2018
Completion date December 29, 2021
View Details
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