Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS)

Hydoxyurea Exposure in Lactation: A Pharmacokinetics Study (HELPS)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02990598

Acronym

HELPS

Enrollment

Registered

2016-12-13

Start date

2017-03-20

Completion date

2018-06-19

Last updated

2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Anemia

Keywords

Hydroxyurea

Brief summary

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 99 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Hydroxyurea Concentration	31-Dec-2019	Hydroxyurea concentration for each collected specimen will be analyzed and summarized.

Countries

United States

Outcome results