Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS)
NCT ID: NCT02990598
Last Updated: 2019-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
16 participants
OBSERVATIONAL
2017-03-20
2018-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Willingness to limit the baby's exposure to hydroxyurea through breastmilk, such as healthy volunteers using the "pump and dump" technique or avoiding direct breastfeeding or collection of pumped milk for at least 8 hours after taking the hydroxyurea dose. This applies only to healthy controls or women with sickle cell who are not already taking hydroxyurea. Women with sickle cell already taking hydroxyurea may continue to breastfeed their infants.
Exclusion Criteria
* Failure to sign informed consent, or inability to undergo informed consent process
* Persons for whom it is not feasible or medically advisable to obtain the specimens necessary for this study
18 Years
99 Years
FEMALE
Yes
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Russell Ware, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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2016-7590_HELPS
Identifier Type: -
Identifier Source: org_study_id
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