<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02990598</url>
  </required_header>
  <id_info>
    <org_study_id>2016-7590_HELPS</org_study_id>
    <nct_id>NCT02990598</nct_id>
  </id_info>
  <brief_title>Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS)</brief_title>
  <acronym>HELPS</acronym>
  <official_title>Hydoxyurea Exposure in Lactation: A Pharmacokinetics Study (HELPS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To examine the pharmacokinetics and distribution of oral hydroxyurea when administered as a&#xD;
      single dose to lactating women&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2017</start_date>
  <completion_date type="Actual">June 19, 2018</completion_date>
  <primary_completion_date type="Actual">June 19, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hydroxyurea Concentration</measure>
    <time_frame>31-Dec-2019</time_frame>
    <description>Hydroxyurea concentration for each collected specimen will be analyzed and summarized.</description>
  </primary_outcome>
  <enrollment type="Actual">16</enrollment>
  <condition>Sickle Cell Anemia</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      1. To obtain blood, urine, and breastmilk samples for pharmacokinetics calculations using a&#xD;
      scheduled collection and analysis strategy. 2. To calculate distribution ratios for&#xD;
      hydroxyurea across compartments, especially plasma to milk; and 3. To create population PK&#xD;
      profiles for hydroxyurea to help calculate potential infant drug exposure&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy Controls and Women taking Hydroxyurea prescribed by treating physician and&#xD;
        lactating&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lactating females, ≥ 18.0 years of age, at the time of enrollment&#xD;
&#xD;
          -  Willingness to limit the baby's exposure to hydroxyurea through breastmilk, such as&#xD;
             healthy volunteers using the &quot;pump and dump&quot; technique or avoiding direct&#xD;
             breastfeeding or collection of pumped milk for at least 8 hours after taking the&#xD;
             hydroxyurea dose. This applies only to healthy controls or women with sickle cell who&#xD;
             are not already taking hydroxyurea. Women with sickle cell already taking hydroxyurea&#xD;
             may continue to breastfeed their infants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons with known allergies to hydroxyurea&#xD;
&#xD;
          -  Failure to sign informed consent, or inability to undergo informed consent process&#xD;
&#xD;
          -  Persons for whom it is not feasible or medically advisable to obtain the specimens&#xD;
             necessary for this study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Russell Ware, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>August 22, 2019</last_update_submitted>
  <last_update_submitted_qc>August 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hydroxyurea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Sickle Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02990598
org study id: 2016-7590_HELPS
nct id: NCT02990598
lead sponsor: 
has dmc: No
To examine the pharmacokinetics and distribution of oral hydroxyurea when administered as a
      single dose to lactating women
observational model: Other
time perspective: Prospective
measure: Hydroxyurea Concentration
time frame: 31-Dec-2019
description: Hydroxyurea concentration for each collected specimen will be analyzed and summarized.
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
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Russell Ware, MD, PhD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anemia, Sickle Cell
sharing ipd: No