Hydroxyurea to Prevent Organ Damage in Children With Sickle Cell Anemia

Summary

The purpose of this study is to determine if hydroxyurea therapy is effective in the prevention of chronic end organ damage in pediatric patients with sickle cell anemia.

Conditions

• Hematologic Diseases
• Anemia, Sickle Cell

Interventions

DRUG

Hydroxyurea

Participants will receive hydroxyurea.

DRUG

Placebo

Participants will receive placebo.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  lead NIH

Principal Investigators

• Sherron Jackson, MD · Medical University of South Carolina

• James F. Casella, MD · Johns Hopkins University

• Lori Luchtman-Jones, MD · Children's National Research Institute

• Rathi V. Iyer, MD · University of Mississippi Medical Center

• Scott T. Miller, MD · SUNY Health Science Center, Brooklyn

• Sohail R. Rana, MD · Howard University

• Zora R. Rogers, MD · University of Texas SW Medical Center

• Bruce W Thompson, Ph.D. · Clinical Trials and Surveys Corp

• Julio Barredo, MD · University of Miami Medical Center

• Winfred C. Wang, MD · St. Jude Children's Research Hospital

• Courtney Thornburg, MD · Duke University

• Thomas Howard, MD · University of Alabama at Birmingham

• Lori Luck, MD · Drexel University

• R. Clark Brown, MD, PhD · Emory University

• Sharada Sarnaik, MD · Wayne State University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

9 Months

Max Age

18 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-08-31

Primary Completion

2009-09-30

Completion

2009-09-30

Countries

• United States

Study Locations