Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS)

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Sickle Cell Anemia

Study type: Observational

Funder types: Other

Identifiers

NCT02990598

2016-7590_HELPS

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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