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

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ClinicalTrials.gov Identifier: NCT02990598
Recruitment Status : Active, not recruiting
First Posted : December 13, 2016
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease
Sickle Cell Anemia

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Hydoxyurea Exposure in Lactation: A Pharmacokinetics Study (HELPS)
Study Start Date : October 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Hydroxyurea Concentration [ Time Frame: 31-Dec-2019 ]
    Hydroxyurea concentration for each collected specimen will be analyzed and summarized.


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


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy Controls and Women taking Hydroxyurea prescribed by treating physician and lactating
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990598


Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Russell Ware, MD, PhD Children's Hospital Medical Center, Cincinnati

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02990598     History of Changes
Other Study ID Numbers: 2016-7590_HELPS
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Hydroxyurea

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn