Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS) (HELPS)

Hydoxyurea Exposure in Lactation: A Pharmacokinetics Study (HELPS)

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

Study Overview

• Status: Completed
• Conditions: Sickle Cell Anemia

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy Controls and Women taking Hydroxyurea prescribed by treating physician and lactating

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Russell Ware, MD, PhD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Actual): June 19, 2018
• Study Completion (Actual): June 19, 2018

Study Registration Dates

• First Submitted: December 9, 2016
• First Submitted That Met QC Criteria: December 9, 2016
• First Posted (Estimate): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): August 26, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Hydroxyurea
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: 2016-7590_HELPS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO