Sickle Cell Anemia Clinical Trial
— BABY HUGOfficial title:
Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol
Verified date | September 2016 |
Source | National Heart, Lung, and Blood Institute (NHLBI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | December 31, 2016 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 24 Months to 18 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory University School of Medicine | Atlanta | Georgia |
United States | Johns Hopkins University School of Medicine | Baltimore | Maryland |
United States | Sinai Hospital of Baltimore Alfred I Coplan Pediatric Hematology Oncology Outpatient Center | Baltimore | Maryland |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Downstate Medical Center | Brooklyn | New York |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | University of Texas Southwestern Medical Center at Dallas | Dallas | Texas |
United States | Children's Hospital of Michigan/Wayne State University | Detroit | Michigan |
United States | Duke University Medical Center | Durham | North Carolina |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
United States | University of Miami School of Medicine | Miami | Florida |
United States | Children's National Medical Center Center for Cancer and Blood Disorders | Washington | District of Columbia |
United States | Howard University College of Medicine | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Qualitative Spleen Function From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo | The change in splenic function from the randomized control trial baseline measurement was one of the primary outcomes. The change in splenic function (worse vs not-worse) was compared between the randomized treatment groups (hydroxyurea vs placebo). The change in splenic function from baseline (before treatment initiation) to age 10 years (a visit when child turned 10 years old) was defined as worse if it changed from normal to decreased or absent, or decreased to absent; and not worse if it changed from decreased to decreased, normal to normal, decreased to normal, absent to absent, or absent to decreased. | baseline and when child turned 10 years old | |
Primary | Change in Qualitative Spleen Function From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit | The change in splenic function from the randomized control trial baseline measurement was one of the primary outcomes. The change in splenic function (worse vs not-worse) was compared between children who were known to be on hydroxyurea vs. off hydroxyurea at the time of the visit. The change in splenic function from baseline (before treatment initiation) to age 10 years (a visit when child turned 10 years old) was defined as worse if it changed from normal to decreased or absent, or decreased to absent; and not worse if it changed from decreased to decreased, normal to normal, decreased to normal, absent to absent, or absent to decreased. | baseline and when child turned 10 years old | |
Primary | Change in the Percentage of Pitted Cell From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo | The change in the percentage of pitted cell from randomized control trial baseline measurement was one of the primary outcomes. The change in the percentage of pitted cell was compared between the randomized treatment groups (hydroxyurea vs placebo). | Baseline and End of follow-up II study (up to 13 years from randomization date) | |
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 | The change in the percentage of pitted cell from the randomized control trial baseline measurement was one of the primary outcomes. The change in the percentage of pitted cell was compared between children who were known to be on hydroxyurea vs. off hydroxyurea at the time of the visit. | Baseline and End of follow-up II study (up to 13 years from randomization date) | |
Primary | Change in Howell Jolly Body (HJB) From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo | The change in Howell Jolly Body from the randomized control trial baseline measurement was one of the primary outcomes. The change in Howell Jolly Body was compared between the randomized treatment groups (hydroxyurea vs placebo). | Baseline and End of follow-up II study (up to 13 years from randomization date) | |
Primary | Change in Howell Jolly Body (HJB) Count From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea | The change in Howell Jolly Body count from the randomized control trial baseline measurement was one of the primary outcomes. The change in Howell-Jolly Bodies was compared between children who were known to be on hydroxyurea vs. off hydroxyurea at the time of the visit. | Baseline and End of follow-up II study (up to 13 years from randomization date) |
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