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NCT02990598 Clinical Trial

Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS)

Sickle Cell Anemia Clinical Trial

— HELPS  

Official title:
Hydoxyurea Exposure in Lactation: A Pharmacokinetics Study (HELPS)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02990598
Other study ID # 2016-7590_HELPS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 20, 2017
Est. completion date June 19, 2018

Study information
Verified date August 2019
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date June 19, 2018
Est. primary completion date June 19, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 99 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

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