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Hydroxyurea in Young Children With Sickle Cell Anemia

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sickle Cell Anemia

Intervention: hydroxyurea (Drug)

Phase: N/A

Status: Completed

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Courtney D Thornburg, MD mS, Principal Investigator, Affiliation: Duke University

Summary

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Transcranial doppler ultrasound velocity

Magnetic resonance imaging/angiography

Glomerular Filtration Rate

Quality of Life

Neurocognitive outcomes

Secondary outcome:

Growth parameters

Hematological parameters

Detailed description: 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

Eligibility

Minimum age: 18 Months. Maximum age: 5 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

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

Locations and Contacts

Duke University Medican Center, Durham, North Carolina 27710, United States
Additional Information

Starting date: April 2002
Last updated: August 22, 2007

Page last updated: August 23, 2015

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