Hydroxyurea

Generic Name: Hydroxyurea

Brand Names: Droxia, Hydrea, Siklos, Xromi

Drug Type: Small Molecule

Chemical Formula: CH_₄N_₂O_₂

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

Clinical Trials

Stroke Prevention in Young Adults With Sickle Cell Anemia

Active, not recruiting

Conditions: Silent Stroke
Silent Cerebral Infarct
Stroke
Sickle Cell Disease
Sickle Cell Anemia
Stroke, Ischemic

Interventions: Drug: Hydroxyurea therapy per standard care

First Posted Date: 2021-03-22

Last Posted Date: 2024-08-09

Lead Sponsor: Vanderbilt University Medical Center

Target Recruit Count: 250

Registration Number: NCT04808778

Locations: 🇳🇬
Aminu Kano Teaching Hospital, Kano, Nigeria
🇺🇸
Vanderbilt University Medical Center, Nashville, Tennessee, United States

Hydroxyurea Therapy for Neurological and Cognitive Protection in Pediatric Sickle Cell Anemia in Uganda ( BRAINSAFE-II )

Phase 3

Completed

Conditions: Sickle Cell Anemia in Children

Interventions: Drug: Hydroxyurea

First Posted Date: 2021-02-11

Last Posted Date: 2025-04-17

Lead Sponsor: Global Health Uganda LTD

Target Recruit Count: 270

Registration Number: NCT04750707

Locations: 🇺🇬
Global Health Uganda, Kampala, Uganda

ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension Study

Active, not recruiting

Conditions: Sickle Cell Disease

Interventions: Drug: Hydroxycarbamide

First Posted Date: 2021-01-13

Last Posted Date: 2024-08-27

Lead Sponsor: Theravia

Target Recruit Count: 2093

Registration Number: NCT04707235

Locations: 🇫🇷
Bordeaux Hospital Adults, Bordeaux, France
🇫🇷
Bordeaux Hospital Children, Bordeaux, France
🇫🇷
Tours Regional University Hospital Center Adults, Chambray-lès-Tours, France

and more 84 locations

Jaktinib Versus Hydroxycarbamide in Subjects With Intermediate-2 or High-risk Myelofibrosis

Phase 3

Completed

Conditions: Myelofibrosis

Interventions: Drug: Hydroxycarbamide Tablets
Drug: Jaktinib
Drug: Placebo to match Hydroxycarbamide
Drug: Placebo to match Jaktinib

First Posted Date: 2020-11-05

Last Posted Date: 2023-11-13

Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Target Recruit Count: 105

Registration Number: NCT04617028

Locations: 🇨🇳
The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou, Zhejiang, China

Hydroxy Urea, Omega 3, Nigella Sativa,Honey on Oxidative Stress and Iron Chelation in Pediatric Major Thalassemia

Phase 2

Completed

Conditions: Iron Overload
Oxidative Stress
Thalassemia Major

Interventions: Drug: Nigella Sativa Oil
Drug: Omega 3
Drug: Hydroxyurea
Drug: Honey
Drug: Deferoxamine
Procedure: blood transfusion session

First Posted Date: 2020-03-03

Last Posted Date: 2021-01-27

Lead Sponsor: Beni-Suef University

Target Recruit Count: 350

Registration Number: NCT04292314

Locations: 🇸🇦
Maternity and Children hospital, Mecca, Saudi Arabia
🇪🇬
Health insurance hospital, Banī Suwayf, Egypt
🇪🇬
Faculty of medicine, Beni-suef univeristy - Beni-Suef university hospital, Banī Suwayf, Egypt

and more 1 locations

Study of Stem Cell Transplant vs. Non-Transplant Therapies in High-Risk Myelofibrosis

Recruiting

Conditions: Bone Marrow Cancer
High-Risk Cancer
Myelofibrosis

Interventions: Biological: Hematopoietic stem cell transplant
Drug: Ruxolitinib
Drug: Hydroxyurea

First Posted Date: 2020-01-03

Last Posted Date: 2024-03-22

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 90

Registration Number: NCT04217356

Locations: 🇨🇦
St. Paul's Hospital, Vancouver, British Columbia, Canada
🇨🇦
Cross Cancer Institute, Edmonton, Alberta, Canada
🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada

and more 2 locations

A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase

Phase 2

Completed

Conditions: Chronic Myeloid Leukemia, Chronic Phase

Interventions: Drug: Hydroxyurea or Interferon-based therapy
Drug: HQP1351
Drug: Homoharringtonine
Drug: Imatinib, Dasatinib or Nilotinib

First Posted Date: 2019-10-15

Last Posted Date: 2025-03-03

Lead Sponsor: Ascentage Pharma Group Inc.

Target Recruit Count: 144

Registration Number: NCT04126681

Locations: 🇨🇳
Nanfang hospital of southern medical university, Guangzhou, Guangdong, China
🇨🇳
Union Hospital medical college Huazhong University of Science and Technology, Wuhan, Hubei, China
🇨🇳
The First Affiliated Hospital, Zhejiang University School of Medicine(hematology dept), Hangzhou, Zhejiang, China

and more 19 locations

MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera

Phase 3

Recruiting

Conditions: Polycythemia Vera

Interventions: Drug: Ruxolitinib
Drug: Hydroxycarbamide
Drug: Interferon-Alpha

First Posted Date: 2019-10-04

Last Posted Date: 2024-11-18

Lead Sponsor: University of Birmingham

Target Recruit Count: 586

Registration Number: NCT04116502

Locations: 🇬🇧
Royal United Hospital, Bath, United Kingdom
🇬🇧
Belfast City Hospital, Belfast, United Kingdom
🇬🇧
Southmead Hospital, Bristol, United Kingdom

and more 44 locations

Stroke Prevention With Hydroxyurea Enabled Through Research and Education (SPHERE)

Phase 2

Conditions: Sickle Cell Anemia in Children

Interventions: Drug: Hydroxyurea
Diagnostic Test: Normal Arm TCD Examination
Diagnostic Test: Elevated Arm TCD Examination

First Posted Date: 2019-05-14

Last Posted Date: 2023-08-01

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Target Recruit Count: 202

Registration Number: NCT03948867

Locations: 🇺🇸
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
🇹🇿
Bugando Medical Centre, Mwanza, Tanzania

De-Escalation Therapy for Human Papillomavirus Negative Disease

Phase 2

Completed

Conditions: Human Papilloma Virus
Squamous Cell Carcinoma
Squamous Cell Carcinoma of the Head and Neck
HPV-Related Squamous Cell Carcinoma
HNSCC

Interventions: Drug: Carboplatin
Drug: Paclitaxel
Radiation: Radiation
Drug: Nivolumab
Drug: Hydroxyurea Pill
Drug: 5-fluorouracil
Drug: Filgrastim Injection
Drug: Cisplatin

First Posted Date: 2019-05-10

Last Posted Date: 2025-05-11

Lead Sponsor: University of Chicago

Target Recruit Count: 35

Registration Number: NCT03944915

Locations: 🇺🇸
University Of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, United States

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