Non-Therapeutic Protocol
HUG3: Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) -- Follow-Up Observational Study II
Type of Protocol/Clinical Study
Associated Hematology Studies : Sickle cell disease
Description
This is a BABY HUG II study follow-up to learn about the long-term effects of the drug hydroxyurea (HU). The BABY HUG study found that treatment with HU in very young children with sickle cell anemia did not prevent organ damage in the primary endpoints of the spleen and kidneys, but did prevent painful crises, dactylitis, acute chest syndrome and hospitalizations.
The purpose of HUG3 is to study the long-term safety and efficacy of HU treatment in children. Follow-up of the BABY HUG cohort will provide important information about whether HU treatment should be given to infants and the best age to begin treatment.
Objectives
- To study the long-term effects (both good and bad) in children who receive treatment with HU.
- To find out if extended treatment with HU changes the risk and benefits of its use.
- To find out the best age for the start of treatment with HU (early vs. late).
Eligibility
Inclusion Criteria
Participant was enrolled in the HUG2 study for at least 24 months.
Exclusion Criteria
Participant received a stem cell transplant.
Principal Investigator
Winfred Wang, MD
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