CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 193 enrolled
Drug / intervention
Hydroxyurea +1 moredrug
Likely dose
Hydroxyurea dose not specified in eligibility or arms textAI-extracted
Key inclusion· 1
  • ✓Majority fetal and sickle (FS or SF) hemoglobin pattern confirmed centrally by hemoglobin electrophoresis
Key exclusion· 8
  • ✕Prior or current treatment with hydroxyurea or another anti-sickling drug
  • ✕Chronic transfusion therapy
  • ✕Severe developmental delay (e.g., cerebral palsy, mental retardation, Grade III/IV intraventricular hemorrhage)
  • ✕Stroke with neurological deficit

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00006400
NCT00006400Phase 3Completed
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Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)

National Heart, Lung, and Blood Institute (NHLBI)·interventional·Posted Oct 13, 2000·Updated Aug 19, 2020

In Brief

A Phase 3 clinical trial evaluating Hydroxyurea and Placebo for Hematologic Diseases and Anemia, Sickle Cell. Completed, enrolled 193 participants across 14 sites.

Detailed Summary

The purpose of this study is to determine if hydroxyurea therapy is effective in the prevention of chronic end organ damage in pediatric patients with sickle cell anemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematologic Diseases, Anemia, Sickle Cell
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 13, 2000
Enrollment StartAug 1, 2000
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 25.7 years ago

Interventions

Hydroxyureadrug

Participants will receive hydroxyurea.

Placebodrug

Participants will receive placebo.