Trial Profile

Optimizing Hydroxyurea Therapy in Children With Sickle Cell Anemia In Malaria Endemic Areas: The NOHARM Maximum Tolerated Dose (MTD) Study

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 04 Nov 2021

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At a glance

25 Jun 2020 After 12 months of trial treatment and quarterly data analyses, the board noted significant differences between the treatment groups in clinical adverse events and medical intervention; dose escalation was superior, which led to the unanimous recommendation of the board to halt the randomized treatment and to offer all the children hydroxyurea treatment with dose escalation as per the results published in the New England Journal of Medicine.
25 Jun 2020 Results analysing whether escalation to the maximum tolerated dose confers clinical benefits that outweigh treatment-related toxic effects, published in the New England Journal of Medicine.
19 Feb 2020 Status changed from active, no longer recruiting to completed.

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