NCT02990598CompletedNot Applicable
Hydoxyurea Exposure in Lactation: A Pharmacokinetics Study (HELPS)
Children's Hospital Medical Center, Cincinnati1 site in 1 country16 target enrollmentStarted: March 20, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Hydroxyurea Concentration
Study Overview
Brief Summary
To examine the pharmacokinetics and distribution of oral hydroxyurea when administered as a single dose to lactating women
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Lactating females, ≥ 18.0 years of age, at the time of enrollment
- •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
- •Persons with known allergies to hydroxyurea
- •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
Outcomes
Primary Outcomes
Hydroxyurea Concentration
Time Frame: 31-Dec-2019
Hydroxyurea concentration for each collected specimen will be analyzed and summarized.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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