N/A
N=150
Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol
Sickle Cell Anemia
Bottom Line
View on ClinicalTrials.gov: NCT01783990 ↗Enrolled (actual)
150
Serious AEs
36.7%
Results posted
Aug 2020
Primary outcome: Primary: Change in Qualitative Spleen Function From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo — 26; 28; 32; 22 Participants — p=0.33
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Hydroxyurea (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Qualitative Spleen Function From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo |
26; 28; 32; 22 | 0.33 |
| PRIMARY Change in Qualitative Spleen Function From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit |
43; 9; 45; 8 | 0.80 |
| PRIMARY Change in the Percentage of Pitted Cell From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo |
-1.60; -1.75 | 0.87 |
| PRIMARY Change in the Percentage of Pitted Cell From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit |
-1.80; -0.80 | 0.28 |
| PRIMARY Change in Howell Jolly Body (HJB) From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo |
2719.88; 2248.55 | 0.31 |
| PRIMARY Change in Howell Jolly Body (HJB) Count From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea |
2645.43; 1833.73 | 0.04 sig |
Summary
The BABY HUG Treatment Study was designed to see if treatment with the drug hydroxyurea (also called HU) in children with sickle cell disease could prevent organ damage, especially in the spleen and kidneys. There was also a chance that treatment could prevent painful crises, lung disease, stroke, and blood infection.
Eligibility Criteria
Inclusion Criteria
- All subjects enrolled in the BABY HUG Follow-Up I Study who participated for at least 24 months are eligible for the Follow-Up Study II
Exclusion Criteria
- Subjects that have received a Stem Cell Transplant are not eligible for enrollment
Data sourced from ClinicalTrials.gov (NCT01783990). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.