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

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ClinicalTrials.gov Identifier: NCT02990598
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date December 9, 2016
First Posted Date December 13, 2016
Last Update Posted Date August 26, 2019
Actual Study Start Date March 20, 2017
Actual Primary Completion Date June 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 9, 2016)
Hydroxyurea Concentration [ Time Frame: 31-Dec-2019 ]
Hydroxyurea concentration for each collected specimen will be analyzed and summarized.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS)
Official Title Hydoxyurea Exposure in Lactation: A Pharmacokinetics Study (HELPS)
Brief Summary To examine the pharmacokinetics and distribution of oral hydroxyurea when administered as a single dose to lactating women
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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
Sampling Method Non-Probability Sample
Study Population Healthy Controls and Women taking Hydroxyurea prescribed by treating physician and lactating
Condition Sickle Cell Anemia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 22, 2019)
16
Original Estimated Enrollment
 (submitted: December 9, 2016)
20
Actual Study Completion Date June 19, 2018
Actual Primary Completion Date June 19, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02990598
Other Study ID Numbers 2016-7590_HELPS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators Not Provided
Investigators
Principal Investigator: Russell Ware, MD, PhD Children's Hospital Medical Center, Cincinnati
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date August 2019