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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


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

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