Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Hydoxyurea Exposure in Lactation: A Pharmacokinetics Study (HELPS)
Actual Study Start Date : March 20, 2017
Actual Primary Completion Date : June 19, 2018
Actual Study Completion Date : June 19, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Layout table for investigator information
Principal Investigator: Russell Ware, MD, PhD Children's Hospital Medical Center, Cincinnati
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02990598    
Other Study ID Numbers: 2016-7590_HELPS
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
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:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn