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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


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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