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Home > "P" Clinical Trials Conditions > Pediatric Hydroxyurea in Sickle Cell Anemia (BABY HUG)  Pediatric Hydroxyurea in Sickle Cell Anemia (BABY HUG)
Pediatric Hydroxyurea in Sickle Cell Anemia (BABY HUG)
For Condition: Anemia, Sickle Cell,Blood Disease
Status: No longer recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To determine if hydroxyurea therapy is effective in the prevention of chronic end organ damage in pediatric patients with sickle cell anemia.
Details: BACKGROUND: In 1995, the Multicenter Study of Hydroxyurea (MSH Trial) demonstrated that hydroxyurea is effective in decreasing the frequency of painful crises, hospitalizations for crises, acute chest syndrome, and blood transfusions by 50 percent. The recently completed phase II study of hydroxyurea in children (PED HUG) demonstrated that children have a response to hydroxyurea similar to that seen in adults in terms of increasing fetal hemoglobin levels and total hemoglobin, and decreasing complications associated with sickle cell anemia. In addition, this study demonstrated that the drug does not adversely affect growth and development between the ages of 5 and 15. A recently completed pilot study of hydroxyurea given to children between the ages of 6 months and 24 months demonstrated that the drug is tolerated well by small infants, and that the fetal hemoglobin switch can be forced to remain in the 'on position' by hydroxyurea administration. A Special Emphasis Panel (SEP) met on April 12, 1996 to review the results of the MSH Trial and the progress to date of the PED HUG study. The SEP recommended that the NHLBI undertake the BABY HUG trial. DESIGN NARRATIVE: BABY HUG is a randomized, double blind, placebo controlled trial to determine if hydroxyurea can prevent the onset of chronic end organ damage in young children with sickle cell anemia. Approximately 200 children with sickle cell disease willl be recruited to receive either hydroxyurea or placebo. The children will be screened at trial start-up for signs of abnormal brain, renal, pulmonary, and splenic function, and for developmental milestones. They will then be randomly assigned to receive either hydroxyurea or placebo and followed with yearly studies of chronic end organ damage of the major organ systems. The primary endpoints will be a 50 percent reduction in rates of damage to the major organs with surrogate markers of organ function to be used during follow-up in Phase II of the trial.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: /2 Years
Genders: Both
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JulioBarredo, , Medical University of South Carolina
Additional Information:
Study ID Numbers: 89;
Study Start Date: August 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006400
Other Blood Disease Studies:
1. L-glutamine Therapy for Sickle Cell Anemia
2. Penicillin Prophylaxis in Sickle Cell Disease (PROPS)
3. Induction of Stable Chimerism for Sickle Cell Anemia
4. Investigation of Selected Patient Groups From The Cooperative Study of Sickle Cell Disease
5. Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients
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Pediatric Hydroxyurea in Sickle Cell Anemia (BABY HUG)
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