NCT00519701

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2007

Completed
Last Updated

August 23, 2007

Status Verified

August 1, 2007

First QC Date

August 21, 2007

Last Update Submit

August 22, 2007

Conditions

Sickle Cell Anemia

Keywords

sickle cell anemiahydroxyurea

Outcome Measures

Primary Outcomes (5)

  • Transcranial doppler ultrasound velocity

    2 years

  • Magnetic resonance imaging/angiography

    2 years

  • Glomerular Filtration Rate

    2 years

  • Quality of Life

    2 years

  • Neurocognitive outcomes

    2 years

Secondary Outcomes (2)

  • Growth parameters

    2 years

  • Hematological parameters

    2 years

Study Arms (1)

1

EXPERIMENTAL

hydroxyurea

Drug: hydroxyurea

Interventions

hydroxyureaDRUG
1

Eligibility Criteria

Age18 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medican Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Hydroxyurea

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

UreaAmidesOrganic Chemicals

Study Officials

  • Courtney D Thornburg, MD mS

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 21, 2007

First Posted

August 23, 2007

Study Start

April 1, 2002

Study Completion

February 1, 2007

Last Updated

August 23, 2007

Record last verified: 2007-08

Locations

US(1)