NCT00000602: PED HUG: pediatric hydroxyurea safety research

Medicine Signal Editorial Desk
Updated 2026-10-10

Registry status when checked 2026-10-10Completed

This record identifies the pediatric hydroxyurea research program PED HUG and links the original HUG-KIDS phase I/II study in sickle-cell anemia. It is not the separately named BABY HUG trial. 1 2 3

The linked research enrolled 84 children; 68 reached the maximum tolerated dose, and 52 completed one year of treatment at that dose. These denominators describe different milestones and should not be interchanged. The program examined tolerability, hematological effects, and concerns about treatment during childhood, with the historical registry recording completion in 1997. 1 2 3

The original 1999 safety publication was located. This early-phase design and its one-year treatment cohort should not be presented as a randomized demonstration of long-term organ preservation or lifelong safety. Those questions require their own outcome evidence. 3

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00000602. Original study registration: sponsor, design, population, endpoints and dated history.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00000602. Original study registration: sponsor, design, population, endpoints and dated history.

2. ICH GCP — ICH GCP — readable reproduction of the sponsor-submitted ClinicalTrials.gov record. Supports the registration details quoted here; not an independent clinical-results publication.Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.

3. PubMed — Original HUG-KIDS safety publication: Kinney et al., 1999Research publication · Publication abstract read via Europe PMC; identifier and title cross-checked. Checked 2026-10-10. Full paper was not independently re-read for this update; abstract details should not be extended beyond what it reports.