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Completed

NCT Number: NCT02990598

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

Completed

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

Female

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Hydroxyurea Concentration

    Time frame: 31-Dec-2019

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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Hydoxyurea Exposure in Lactation: A Pharmacokinetics Study (HELPS)

Acronym: HELPS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 13, 2016
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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