Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol

Completed

Conditions studied: Sickle Cell Anemia

In brief

The BABY HUG Treatment Study was designed to see if treatment with the drug hydroxyurea (also called HU) in children with sickle cell disease could prevent organ damage, especially in the spleen and kidneys. There was also a chance that treatment could prevent painful crises, lung disease, stroke, and blood infection.

Key facts

Study ID

NCT01783990

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

150

Starts

2012-10-01

Expected to finish

2016-12-31

Last updated by the study team

2020-08-20

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All subjects enrolled in the BABY HUG Follow-Up I Study who participated for at least 24 months are eligible for the Follow-Up Study II

You may not qualify if…

• Subjects that have received a Stem Cell Transplant are not eligible for enrollment

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Children's National Medical Center Center for Cancer and Blood Disorders — Washington D.C., District of Columbia, United States
• Howard University College of Medicine — Washington D.C., District of Columbia, United States
• University of Miami School of Medicine — Miami, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Sinai Hospital of Baltimore Alfred I Coplan Pediatric Hematology Oncology Outpatient Center — Baltimore, Maryland, United States
• Children's Hospital of Michigan/Wayne State University — Detroit, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Downstate Medical Center — Brooklyn, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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