MedPath

Hydroxyurea

Generic Name
Hydroxyurea
Brand Names
Droxia, Hydrea, Siklos, Xromi
Drug Type
Small Molecule
Chemical Formula
CH4N2O2
CAS Number
127-07-1
Unique Ingredient Identifier
X6Q56QN5QC
Background

An antineoplastic agent that inhibits DNA synthesis through the inhibition of ribonucleoside diphosphate reductase.

Indication

Hydroxyurea is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises.

Associated Conditions
Chronic Myelogenous Leukemia (CML), Essential Thrombocythemia (ET), Head and Neck Primary Squamous Cell Carcinoma, Hypereosinophilic Syndrome (HES), Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN), Meningiomas, Polycythemia Vera (PV), Sickle Cell Crisis, Vaso-occlusive Crisis
Associated Therapies
Chemoradiotherapy, Radiation Therapy

Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

First Posted Date
2019-03-04
Last Posted Date
2024-05-16
Lead Sponsor
Sanofi
Target Recruit Count
67
Registration Number
NCT03860844
Locations
🇺🇸

Children's Medical Center of Dallas-Site Number:8400002, Dallas, Texas, United States

🇲🇽

Investigational Site Number :4840001, Monterrey, Nuevo León, Mexico

🇧🇷

Investigational Site Number :0760007, Porto Alegre, Rio Grande Do Sul, Brazil

and more 38 locations

Hydroxyurea Therapy: Optimizing Access in Pediatric Populations Everywhere

Phase 2
Terminated
Conditions
Sickle Cell Disease
Thalassemia
Interventions
First Posted Date
2019-01-31
Last Posted Date
2022-03-18
Lead Sponsor
St. Jude Children's Research Hospital
Target Recruit Count
1
Registration Number
NCT03825341
Locations
🇺🇸

St. Jude Children's Research Hospital, Memphis, Tennessee, United States

SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial)

Phase 2
Completed
Conditions
Sickle Cell Disease
Interventions
Drug: Placebo Oral Tablet
First Posted Date
2019-01-16
Last Posted Date
2025-05-14
Lead Sponsor
Theravia
Target Recruit Count
86
Registration Number
NCT03806452
Locations
🇲🇱

Centre de Recherche et de Lutte contre la Drépanocytose de Bamako (CRLD), Bamako, Mali

🇬🇵

CHU Pointe-à-Pitre/Abymes, Pointe-à-Pitre, Guadeloupe

🇫🇷

CHU d'Angers, Angers, France

and more 18 locations

Hydroxyurea Optimization Through Precision Study

Phase 3
Recruiting
Conditions
Sickle Cell Disease
Sickle Cell Anemia
Interventions
First Posted Date
2018-12-28
Last Posted Date
2023-03-13
Lead Sponsor
Children's Hospital Medical Center, Cincinnati
Target Recruit Count
116
Registration Number
NCT03789591
Locations
🇺🇸

Boston Children's Hospital, Boston, Massachusetts, United States

🇺🇸

Cleveland Clinic Children's, Cleveland, Ohio, United States

🇺🇸

Carle Foundation Hospital, Urbana, Illinois, United States

and more 11 locations

Pharmacokinetics of Oral Hydroxyurea Solution

Phase 1
Completed
Conditions
Sickle Cell Disease
Sickle Cell-beta-thalassemia
Sickle Cell Hemoglobin C
Sickle-Cell; Hemoglobin Disease, Thalassemia
Interventions
First Posted Date
2018-12-04
Last Posted Date
2024-10-28
Lead Sponsor
Nova Laboratories Limited
Target Recruit Count
33
Registration Number
NCT03763656
Locations
🇯🇲

Dr Angela E Rankine- Mullings, Kingston, Jamaica

🇬🇧

Evelina London Children's Hospital, London, United Kingdom

🇬🇧

King's College Hospital NHS Foundation Trust, London, United Kingdom

and more 3 locations

Cerebrovascular Reserve and White Matter Disease in Patients with Chronic Anemia

Completed
Conditions
Sickle Cell Disease
Thalassemia
Healthy Controls
Interventions
First Posted Date
2018-10-23
Last Posted Date
2024-10-30
Lead Sponsor
Children's Hospital Los Angeles
Target Recruit Count
165
Registration Number
NCT03715972
Locations
🇺🇸

CHLA, Los Angeles, California, United States

T-Cell Depleted Alternative Donor Bone Marrow Transplant for Sickle Cell Disease (SCD) and Other Anemias

Phase 1
Recruiting
Conditions
Diamond-blackfan Anemia
Sickle Cell Anemia
Beta-thalassemia Major
Interventions
Biological: CD3/CD19 depleted leukocytes
Biological: CD45RA depleted leukocytes
First Posted Date
2018-08-31
Last Posted Date
2024-08-09
Lead Sponsor
Paul Szabolcs
Target Recruit Count
5
Registration Number
NCT03653338
Locations
🇺🇸

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States

Hydroxyurea and Transfusion

Phase 2
Completed
Conditions
Sickle Cell Disease
Interventions
First Posted Date
2018-08-23
Last Posted Date
2021-10-21
Lead Sponsor
Children's National Research Institute
Target Recruit Count
14
Registration Number
NCT03644953
Locations
🇺🇸

Children's National Health System, Washington, District of Columbia, United States

Management of Severe Acute Malnutrition in SCD, in Northern Nigeria

Phase 2
Completed
Conditions
Sickle Cell Anemia
Severe Acute Malnutrition
Interventions
Dietary Supplement: Ready-to-use therapeutic food
First Posted Date
2018-08-16
Last Posted Date
2024-03-27
Lead Sponsor
Vanderbilt University Medical Center
Target Recruit Count
132
Registration Number
NCT03634488
Locations
🇺🇸

Vanderbilt University Medical Center, Nashville, Tennessee, United States

🇳🇬

Murtala Mohammad Specialist Hospital, Kano, Nigeria

🇳🇬

Aminu Kano Teaching Hospital, Kano, Nigeria

Evaluation of the Therapeutic Effect of HU Pulse Therapy for CML Patients

Phase 3
Conditions
Leukemia, Chronic Myeloid
Interventions
First Posted Date
2018-05-03
Last Posted Date
2018-05-22
Lead Sponsor
First Affiliated Hospital of Harbin Medical University
Target Recruit Count
60
Registration Number
NCT03515018
Locations
🇨🇳

the First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China

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