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Last Updated: October 16, 2019

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CLINICAL TRIALS PROFILE FOR SIKLOS

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Clinical Trials for SIKLOS

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02516579 European Sickle Cell Disease Cohort - Hydroxyurea Recruiting ADDMEDICA SASA N/A 2009-01-01 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.
NCT02522104 Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH) Recruiting ADDMEDICA SASA Phase 4 2015-09-01 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.
NCT03128515 Optimizing Hydroxyurea Therapy in Children With SCA In Malaria Endemic Areas Not yet recruiting Children's Hospital Medical Center, Cincinnati Phase 3 2017-05-01 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.
NCT03128515 Optimizing Hydroxyurea Therapy in Children With SCA In Malaria Endemic Areas Not yet recruiting Doris Duke Charitable Foundation Phase 3 2017-05-01 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.
NCT03128515 Optimizing Hydroxyurea Therapy in Children With SCA In Malaria Endemic Areas Not yet recruiting Makerere University Phase 3 2017-05-01 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.
NCT03128515 Optimizing Hydroxyurea Therapy in Children With SCA In Malaria Endemic Areas Not yet recruiting Mulago Hospital, Uganda Phase 3 2017-05-01 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.
NCT03128515 Optimizing Hydroxyurea Therapy in Children With SCA In Malaria Endemic Areas Not yet recruiting Indiana University Phase 3 2017-05-01 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for SIKLOS

Condition Name

Condition Name for SIKLOS
Intervention Trials
Sickle Cell Disease 4
Malaria 1
Sickle Cell Anemia 1
Renal Function Disorder 1
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Condition MeSH

Condition MeSH for SIKLOS
Intervention Trials
Anemia, Sickle Cell 4
Albuminuria 1
Malaria 1
Anemia 1
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Clinical Trial Locations for SIKLOS

Trials by Country

Trials by Country for SIKLOS
Location Trials
France 5
Uganda 1
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Clinical Trial Progress for SIKLOS

Clinical Trial Phase

Clinical Trial Phase for SIKLOS
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for SIKLOS
Clinical Trial Phase Trials
Not yet recruiting 2
Recruiting 2
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Clinical Trial Sponsors for SIKLOS

Sponsor Name

Sponsor Name for SIKLOS
Sponsor Trials
ADDMEDICA SASA 3
Mulago Hospital, Uganda 1
Makerere University 1
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Sponsor Type

Sponsor Type for SIKLOS
Sponsor Trials
Other 5
Industry 3
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