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Studies Assess Hydroxyurea Therapy and Pre-Operative Transfusions for Patients with Sickle Cell Disease
Date:12/11/2011

and Efficacy of Continued Treatment -- the BABY HUG Follow-up Study [Abstract 7]

Hydroxyurea is the only federally approved therapy to prevent sickle cell complications in adults with sickle cell anemia (SCA). However, based on positive results from previous trials assessing clinical benefits for use in children, specialists are increasingly considering the use of hydroxyurea in their pediatric patients. Results from the BABY HUG Follow-up Study I suggest that continued use of hydroxyurea is both safe and effective in infants with SCA.

The Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) was a multicenter, randomized clinical trial that assessed the clinical benefits of hydroxyurea in very young patients with SCA. Results from the study demonstrated that hydroxyurea administered to infants with SCA provided substantial clinical benefit over placebo.

Researchers launched the BABY HUG Follow-Up Study I in 2008 to assess the safety and efficacy of continued treatment with hydroxyurea in infants with SCA. The Follow-Up Study I included 163 children between the ages of 28 and 44 months who had participated in the BABY HUG trial and who had completed at least 18 months of randomized treatment of either hydroxyurea or placebo. Investigators collected clinical and laboratory data every six months from patient medical records, including use and dosage of hydroxyurea, blood counts, clinical imaging, and frequency of sickle cell-related complications.

At Follow-Up Study entry, families enrolling their children did not know their child's randomized study treatment assignment in BABY HUG; 82 percent initially chose clinical prescription of open-label hydroxyurea, demonstrating a high acceptance rate for the drug. Through the 36 months of follow-up, acceptance remained high, with 68 to 75 percent of the participating families reporting that their children continued
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SOURCE American Society of Hematology
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