Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS)

Hydoxyurea Exposure in Lactation: A Pharmacokinetics Study (HELPS)


Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Source Children's Hospital Medical Center, Cincinnati
Brief Summary

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

Overall Status Completed
Start Date March 20, 2017
Completion Date June 19, 2018
Primary Completion Date June 19, 2018
Study Type Observational
Primary Outcome
Measure Time Frame
Hydroxyurea Concentration 31-Dec-2019
Enrollment 16

Sampling Method: Non-Probability Sample


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

Gender: Female

Minimum Age: 18 Years

Maximum Age: 99 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Russell Ware, MD, PhD Principal Investigator Children's Hospital Medical Center, Cincinnati
Facility: Cincinnati Children's Hospital Medical Center
Location Countries

United States

Verification Date

August 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Acronym HELPS
Patient Data No
Study Design Info

Observational Model: Other

Time Perspective: Prospective

Source: ClinicalTrials.gov