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Completed

NCT Number: NCT00519701

Hydroxyurea in Young Children With Sickle Cell Anemia

The purpose of this study is to asses prospectively the safety and efficacy of hydroxyurea therapy in children with Sickle cell Anemia between ages 18 months and 5 years, with special emphasis on the ability of hydroxyurea to prevent or reverse chronic organ damage.

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Key information

Conditions

Sickle Cell Anemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

18 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medican Center

Durham, North Carolina, 27710, United States

About this study

Previous studies have shown that hydroxyurea therapy in adults and older children with SCA improves laboratory parameters and ameliorates the clinical severity of disease. Little is known, however, about the effects of hydroxyurea on the chronic organ damage that occurs in patients with SCA and leads to significant morbidity and mortality in young adults. The objectives of this study are to assess the safety and efficacy of HU in young children with SCA and to determine whether HU preserves renal function, reduces transcranial doppler ultrasound (TCD) values, and prevents development of brain ischemia as evidenced by MRI/MRA imaging. In addition, we will evaluate the effects of hydroxyurea on quality of life

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of Sickle Cell Anemia (Hb SS or Hb S beta zero-thalassemia)

Treatment and study plan

Hydroxyurea

Drug

Primary outcomes

  1. Transcranial doppler ultrasound velocity

    Time frame: 2 years

  2. Magnetic resonance imaging/angiography

    Time frame: 2 years

  3. Glomerular Filtration Rate

    Time frame: 2 years

  4. Quality of Life

    Time frame: 2 years

  5. Neurocognitive outcomes

    Time frame: 2 years

Secondary outcomes

  1. Growth parameters

    Time frame: 2 years

  2. Hematological parameters

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Effects of Hydroxyurea on the Prevention of Chronic Organ Damage in Young Children With Sickle Cell Anemia

Important dates

Study start
2002
Study completion
2007
First posted
Aug 23, 2007
Registry last updated
Aug 23, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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