Assessment of Algorithm-Based Hydroxyurea Dosing on Fetal Hemoglobin Response, Acute Complications, and Organ Function in People With Sickle Cell Disease
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| ClinicalTrials.gov Identifier: NCT02225132 |
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Recruitment Status :
Completed
First Posted : August 26, 2014
Results First Posted : August 6, 2019
Last Update Posted : August 6, 2019
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Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Sickle Cell Disease |
| Intervention |
Drug: Hydroxyurea |
| Enrollment | 10 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Hydroxyurea |
|---|---|
 Arm/Group Description |
Hydroxyurea is given to the patients as per a dosing algorithm. |
| Period Title: Overall Study | |
| Started | 10 |
| Completed | 10 |
| Not Completed | 0 |
Baseline Characteristics
| Arm/Group Title | Hydroxyurea | |
|---|---|---|
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Arm/Group Description |
Hydroxyurea is given to the patients as per a dosing algorithm. | |
| Overall Number of Baseline Participants | 10 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 10 participants | |
| <=18 years |
0 0.0%
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| Between 18 and 65 years |
10 100.0%
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| >=65 years |
0 0.0%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 10 participants | |
| Female |
8 80.0%
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| Male |
2 20.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 10 participants | |
| Hispanic or Latino |
0 0.0%
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| Not Hispanic or Latino |
10 100.0%
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| Unknown or Not Reported |
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 10 participants | |
| American Indian or Alaska Native |
0 0.0%
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| Asian |
0 0.0%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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| Black or African American |
10 100.0%
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| White |
0 0.0%
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| More than one race |
0 0.0%
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| Unknown or Not Reported |
0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Fitzhugh, Courtney |
| Organization: | National Heart Lung and Blood Institute |
| Phone: | +1 301 402 6496 |
| EMail: | courtney.fitzhugh@nih.gov |
| Responsible Party: | National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ) |
| ClinicalTrials.gov Identifier: | NCT02225132 |
| Other Study ID Numbers: |
140172 14-H-0172 |
| First Submitted: | August 23, 2014 |
| First Posted: | August 26, 2014 |
| Results First Submitted: | July 15, 2019 |
| Results First Posted: | August 6, 2019 |
| Last Update Posted: | August 6, 2019 |