Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS)

NCT02990598 | Completed

• 1 other identifier: 2016-7590_HELPS
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sickle Cell Anemia

Keywords

Hydroxyurea

Outcome Measures

Primary Outcomes (1)

• Hydroxyurea Concentration

  Hydroxyurea concentration for each collected specimen will be analyzed and summarized.

  31-Dec-2019

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

1\. To obtain blood, urine, and breastmilk samples for pharmacokinetics calculations using a scheduled collection and analysis strategy. 2. To calculate distribution ratios for hydroxyurea across compartments, especially plasma to milk; and 3. To create population PK profiles for hydroxyurea to help calculate potential infant drug exposure

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Russell Ware, MD, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 13, 2016
• Study Start: March 20, 2017
• Primary Completion: June 19, 2018
• Study Completion: June 19, 2018
• Last Updated: August 26, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)