In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA,
to collect information about long-term safety of Siklos® (hydroxycarbamide) when used in
current practices for the prevention of symptomatic vaso-occlusive complications in patients
with Sickle Cell Disease.
Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH)
The use of hydroxyurea in sickle cell disease patients with glomerular hyperfiltration and
renal failure requires a specific monitoring and dose adjustment in order to remain within
the therapeutic interval while limiting the risk of toxicity or therapeutic failure. For
this reason the investigators propose to compare the pharmacokinetic parameters of
hydroxyurea in normal-renal function sickle cell patients to those of patients with
glomerular hyperfiltration or moderate renal failure.
Optimizing Hydroxyurea Therapy in Children With SCA In Malaria Endemic Areas
Not yet recruiting
Children's Hospital Medical Center, Cincinnati
The Novel use Of Hydroxyurea in an African Region with Malaria (NOHARM) study is the first
placebo-controlled randomized clinical trial of hydroxyurea treatment in a malaria endemic
region. NOHARM has now achieved full enrollment; all children have completed the blinded
portion of the protocol and are in the open-label study treatment portion.
This extension study of maximum tolerated dose (MTD), addresses the next critical set of
questions about the optimal dosing and monitoring of hydroxyurea treatment for children with
SCA in low-resource settings. By providing guidance about optimal hydroxyurea treatment, the
NOHARM MTD Study will directly inform policies that can transform the health of African
children living with SCA.
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