NCT00000602

Brief Summary

To determine whether hydroxyurea prevents the onset of chronic end organ damage in young children with sickle cell anemia.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 1994

Typical duration for phase_2

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, 1994

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1997

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

September 16, 2016

Status Verified

October 1, 2005

First QC Date

October 27, 1999

Last Update Submit

September 15, 2016

Conditions

Anemia, Sickle CellHematologic DiseasesHemoglobinopathies

Interventions

hydroxyureaDRUG

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Children with sickle cell disease and between the ages of five and eighteen years.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (3)

  • Phase I/II Multicenter Pediatric Trial of Hydroxyurea (HUG-Kids). Blood, 90 (Suppl 1):Abstract # 1974, 1997.

    BACKGROUND

  • Kinney TR, Helms RW, O'Branski EE, Ohene-Frempong K, Wang W, Daeschner C, Vichinsky E, Redding-Lallinger R, Gee B, Platt OS, Ware RE. Safety of hydroxyurea in children with sickle cell anemia: results of the HUG-KIDS study, a phase I/II trial. Pediatric Hydroxyurea Group. Blood. 1999 Sep 1;94(5):1550-4.

    PMID: 10477679BACKGROUND

  • Wang WC, Helms RW, Lynn HS, Redding-Lallinger R, Gee BE, Ohene-Frempong K, Smith-Whitley K, Waclawiw MA, Vichinsky EP, Styles LA, Ware RE, Kinney TR. Effect of hydroxyurea on growth in children with sickle cell anemia: results of the HUG-KIDS Study. J Pediatr. 2002 Feb;140(2):225-9. doi: 10.1067/mpd.2002.121383.

    PMID: 11865275BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle CellHematologic DiseasesHemoglobinopathies

Interventions

Hydroxyurea

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

UreaAmidesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

April 1, 1994

Study Completion

March 1, 1997

Last Updated

September 16, 2016

Record last verified: 2005-10