Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS)

Completed

Conditions studied: Sickle Cell Anemia

In brief

To examine the pharmacokinetics and distribution of oral hydroxyurea when administered as a single dose to lactating women

Key facts

Study ID

NCT02990598

Run by

Children's Hospital Medical Center, Cincinnati

People needed

16

Starts

2017-03-20

Expected to finish

2018-06-19

Last updated by the study team

2019-08-26

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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