<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/NCT03789591</url>
  </required_header>
  <id_info>
    <org_study_id>CCHMC_HOPS</org_study_id>
    <nct_id>NCT03789591</nct_id>
  </id_info>
  <brief_title>Hydroxyurea Optimization Through Precision Study</brief_title>
  <acronym>HOPS</acronym>
  <official_title>Hydroxyurea Optimization Through Precision Study (HOPS): A Prospective, Multi-center, Randomized Trial of Personalized, Pharmacokinetics-guided Dosing of Hydroxyurea Versus Standard Weight-based Dosing for Children With Sickle Cell Anemia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Doris Duke Charitable Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hydroxyurea Optimization through Precision Study (HOPS) is a prospective, multi-center,&#xD;
      randomized trial that will directly compare a novel, individualized dosing strategy of&#xD;
      hydroxyurea to standard weight-based dosing for children with SCA. The primary objective of&#xD;
      the study is to evaluate whether a pharmacokinetics-based starting hydroxyurea dose thieves&#xD;
      superior fetal hemoglobin response to to standard weight-based initial dosing. Patients will&#xD;
      be recruited from the pediatric sickle cell clinic at Cincinnati Children's Hospital Medical&#xD;
      Center and from additional pediatric sickle cell centers within the United States.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial will recruit patients who have decided to initiate hydroxyurea therapy. All&#xD;
      participants will have pharmacokinetics studies performed at baseline, following a 20 mg/kg&#xD;
      oral dose of hydroxyurea. Pharmacokinetic sampling will use a sparse sampling approach,&#xD;
      requiring collection of blood at 3 time points (15 minutes, 60 minutes, 180 minutes)&#xD;
      following the hydroxyurea dose. Enrolled participants will be randomized to receive either&#xD;
      hydroxyurea using a starting dose of 20 mg/kg/day (Standard Arm) or a personalized PK-guided&#xD;
      dose (Alternative Arm) to target an area under the curve (AUC) of 115 mg*h/L based to&#xD;
      approximate hydroxyurea exposure seen when patients are escalated to maximum tolerated dose&#xD;
      (MTD).&#xD;
&#xD;
      Following randomization and selection of the initial dose, participants in both arms will&#xD;
      follow the same procedures of laboratory medication holds for hematological toxicity. The&#xD;
      primary endpoint is fetal hemoglobin (HbF) six months following the initiation of hydroxyurea&#xD;
      therapy with the hypothesis that participants starting with a PK-guided dose will achieve HbF&#xD;
      at least 5% greater than those starting with a 20 mg/kg dose. Based upon the estimated number&#xD;
      of new hydroxyurea starts at each site, it is anticipated that it will take 24 months to&#xD;
      enroll the 116 participants required to achieve sufficient power to assess the primary&#xD;
      endpoint. The study will conclude for each participant 12 months following hydroxyurea&#xD;
      initiation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>The study is designed with a double-blind design. The clinical provider and participant/family will be aware of the absolute (mg) starting dose and could theoretically calculate the mg/kg starting dose, but the treatment assignment will not explicitly be provided to the provider or the family, and the same procedures will be used for dose escalation or reduction. Although most doses in the Alternative Arm will be different than 20 mg/kg, there are some patients on the standard arm who may have a PK-guided dose that is close to or at 20 mg/kg. Thus, although it may be possible to deduce the study arm, the study is designed technically in a double-blind fashion.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fetal Hemoglobin (HbF) Response Following Six Months of Hydroxyurea Therapy</measure>
    <time_frame>6 months after starting daily hydroxyurea therapy</time_frame>
    <description>The primary outcome will be HbF response six months after starting hydroxyurea therapy with the hypothesis that participants in the Alternative Arm (PK-guided starting dose) will have at least 5% higher HbF than the Standard Arm (20 mg/kg starting dose)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>F Cells</measure>
    <time_frame>Baseline, 6 and 12 months after initiating daily hydroxyurea therapy</time_frame>
    <description>In addition to traditional %HbF measurement, F cells will be measured at baseline, 6 months, and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gene Expression Patterns of Study Participants</measure>
    <time_frame>6 Months after initial Hydroxyurea therapy</time_frame>
    <description>The epigenomic signature and gene expression patterns of study participants receiving hydroxyurea therapy at MTD. MTD is defined as a stable dose without any dose increases (except to account for weight gain), holds, or decreases within 8 weeks with laboratory criteria within the target range. This outcome will explain the mechanisms that yield high HbF responses.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">116</enrollment>
  <condition>Sickle Cell Disease</condition>
  <condition>Sickle Cell Anemia</condition>
  <arm_group>
    <arm_group_label>Standard Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to the standard arm will receive a starting dose of hydroxyurea of 20 mg/kg/day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alternative Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to the alternative arm will receive a pharmacokinetic guided starting dose of hydroxyurea based on PK labs drawn at a baseline visit to target an area under the curve (AUC) of 115 mg*h/L in an attempt to approximate maximum tolerated dose (MTD). This dose will not exceed the maximum tolerated dose of 35 mg/kg/day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydroxyurea</intervention_name>
    <description>The alternative arm will use PK data to choose a starting hydroxyurea dose to achieve an AUC of 115 mg*h/L to approximate maximum tolerated dose. On the standard arm, participants will start at the traditional, weight-based dose of 20 mg/kg/day. Following selection of the starting dose, all participants will follow the same dose escalation and laboratory monitoring procedures.</description>
    <arm_group_label>Alternative Arm</arm_group_label>
    <arm_group_label>Standard Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of sickle cell anemia (HbSS, HbSD, HbS/β0-thalassemia, or similarly severe&#xD;
             SCA genotype)&#xD;
&#xD;
          -  Age 6 months to 21 years at the time of enrollment&#xD;
&#xD;
          -  Clinical decision by patient, family, and healthcare providers to initiate hydroxyurea&#xD;
             therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current treatment with chronic, monthly blood transfusions or erythrocytapheresis&#xD;
&#xD;
          -  Treatment with hydroxyurea within the past 3 months&#xD;
&#xD;
          -  Hemoglobin SC disease, HbS/β+-thalassemia&#xD;
&#xD;
          -  Current treatment with other investigational sickle cell medications&#xD;
&#xD;
          -  Current known pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick Niss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lifespan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick McGann, MD</last_name>
    <phone>513-736-2246</phone>
    <email>PMcGann@Lifespan.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Phoenix Children's Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Edrick Villalobos, MPH</last_name>
      <phone>602-933-0170</phone>
      <email>evillalobos1@phoenixchildrens.com</email>
    </contact>
    <investigator>
      <last_name>Maa-Ohui Quarmyne, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Healthcare of Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amanda Wyatt</last_name>
      <phone>404-785-3934</phone>
      <email>Amanda.Wyatt@choa.org</email>
    </contact>
    <contact_backup>
      <last_name>Clark Brown</last_name>
      <email>Clark.Brown@choa.org</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Illinois</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kay Savings, MD</last_name>
      <phone>309-624-4015</phone>
      <email>kls@uic.edu</email>
    </contact>
    <contact_backup>
      <last_name>Nicole Bohnker, MPH</last_name>
      <phone>309-624-4015</phone>
      <email>nbohnker@uic.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Carle Foundation Hospital</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pauline Mbuvi</last_name>
      <phone>517-383-4085</phone>
      <email>Pauline.Mbuvi@carle.com</email>
    </contact>
    <investigator>
      <last_name>Connie Piccone, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Riley Hospital for Children at Indiana University Health</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sara Quetant</last_name>
      <phone>317-948-3395</phone>
      <email>squetant@iu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Jennifer Pencek</last_name>
      <phone>317-944-2832</phone>
    </contact_backup>
    <investigator>
      <last_name>Seethal Jacob, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Indiana Hemophilia &amp; Thrombosis Center, Inc. (IHTC)</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adrianna Williamson, BS, MA</last_name>
      <phone>317-871-0011</phone>
      <phone_ext>283</phone_ext>
      <email>awilliamson@ihtc.org</email>
    </contact>
    <contact_backup>
      <last_name>Emmelise Cho, RN, BSN</last_name>
      <phone>317-871-0011</phone>
      <phone_ext>110</phone_ext>
      <email>echo@ihtc.org</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthew Henney, MD</last_name>
      <phone>617-919-3242</phone>
      <email>Matthew.Heeney@childrens.harvard.edu</email>
    </contact>
    <contact_backup>
      <last_name>Latoya Lashley, MPH</last_name>
      <phone>617-355-7407</phone>
      <email>Latoya.Lashley@childrens.harvard.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Children's Hospitals and Clinics of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephen Nelson, MD</last_name>
      <phone>612-813-5940</phone>
      <email>Stephen.Nelson@childrensmn.org</email>
    </contact>
    <contact_backup>
      <last_name>Ashley Kinsella</last_name>
      <phone>612-813-6969</phone>
      <email>Ashley.Kinsella@childrensmn.org</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Cohen Children's Medical Center/Northwell Health</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alicha Paul</last_name>
      <phone>718-470-3452</phone>
      <email>APaul14@northwell.edu</email>
    </contact>
    <investigator>
      <last_name>Banu Aygun, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Omar Niss, MD</last_name>
      <phone>513-736-2246</phone>
      <email>Omar.Niss@cchmc.org</email>
    </contact>
    <contact_backup>
      <last_name>Amanda Pfeiffer</last_name>
      <phone>513-803-4977</phone>
      <email>Amanda.Pfeiffer@cchmc.org</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Rainbow Babies / University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amanda Rivera</last_name>
      <phone>216-844-4908</phone>
      <email>Amanda.Rivera@UHhospitals.org</email>
    </contact>
    <contact_backup>
      <last_name>Caitlin Tucker</last_name>
      <phone>216-286-0762</phone>
      <email>Caitlin.Tucker@UHhospitals.org</email>
    </contact_backup>
    <investigator>
      <last_name>Valerie Cachat, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Children's</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital.</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Yekisa</last_name>
      <phone>614-722-6570</phone>
      <email>Amy.Yekisa@nationwidechildrens.org</email>
    </contact>
    <contact_backup>
      <last_name>Myra Christian-Rancy</last_name>
      <phone>614-722-3690</phone>
      <email>Myra.Christian-Rancy@nationwidechildrens.org</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>J. Paul Scott, MD</last_name>
      <phone>414-955-4170</phone>
      <email>jpscott@mcw.edu</email>
    </contact>
    <contact_backup>
      <last_name>Dawn Retherford</last_name>
      <phone>414-955-5792</phone>
      <email>dretherf@mcw.edu</email>
    </contact_backup>
    <investigator>
      <last_name>J. Paul Scott, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hydroxyurea</keyword>
  <keyword>HbSS</keyword>
  <keyword>HbSD</keyword>
  <keyword>TREAT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Anemia, Sickle Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydroxyurea</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03789591
org study id: CCHMC_HOPS
nct id: NCT03789591
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Hydroxyurea Optimization through Precision Study (HOPS) is a prospective, multi-center,
      randomized trial that will directly compare a novel, individualized dosing strategy of
      hydroxyurea to standard weight-based dosing for children with SCA. The primary objective of
      the study is to evaluate whether a pharmacokinetics-based starting hydroxyurea dose thieves
      superior fetal hemoglobin response to to standard weight-based initial dosing. Patients will
      be recruited from the pediatric sickle cell clinic at Cincinnati Children's Hospital Medical
      Center and from additional pediatric sickle cell centers within the United States.
The trial will recruit patients who have decided to initiate hydroxyurea therapy. All
      participants will have pharmacokinetics studies performed at baseline, following a 20 mg/kg
      oral dose of hydroxyurea. Pharmacokinetic sampling will use a sparse sampling approach,
      requiring collection of blood at 3 time points (15 minutes, 60 minutes, 180 minutes)
      following the hydroxyurea dose. Enrolled participants will be randomized to receive either
      hydroxyurea using a starting dose of 20 mg/kg/day (Standard Arm) or a personalized PK-guided
      dose (Alternative Arm) to target an area under the curve (AUC) of 115 mg*h/L based to
      approximate hydroxyurea exposure seen when patients are escalated to maximum tolerated dose
      (MTD).

      Following randomization and selection of the initial dose, participants in both arms will
      follow the same procedures of laboratory medication holds for hematological toxicity. The
      primary endpoint is fetal hemoglobin (HbF) six months following the initiation of hydroxyurea
      therapy with the hypothesis that participants starting with a PK-guided dose will achieve HbF
      at least 5% greater than those starting with a 20 mg/kg dose. Based upon the estimated number
      of new hydroxyurea starts at each site, it is anticipated that it will take 24 months to
      enroll the 116 participants required to achieve sufficient power to assess the primary
      endpoint. The study will conclude for each participant 12 months following hydroxyurea
      initiation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
masking description: The study is designed with a double-blind design. The clinical provider and participant/family will be aware of the absolute (mg) starting dose and could theoretically calculate the mg/kg starting dose, but the treatment assignment will not explicitly be provided to the provider or the family, and the same procedures will be used for dose escalation or reduction. Although most doses in the Alternative Arm will be different than 20 mg/kg, there are some patients on the standard arm who may have a PK-guided dose that is close to or at 20 mg/kg. Thus, although it may be possible to deduce the study arm, the study is designed technically in a double-blind fashion.
measure: Fetal Hemoglobin (HbF) Response Following Six Months of Hydroxyurea Therapy
time frame: 6 months after starting daily hydroxyurea therapy
description: The primary outcome will be HbF response six months after starting hydroxyurea therapy with the hypothesis that participants in the Alternative Arm (PK-guided starting dose) will have at least 5% higher HbF than the Standard Arm (20 mg/kg starting dose)
measure: F Cells
time frame: Baseline, 6 and 12 months after initiating daily hydroxyurea therapy
description: In addition to traditional %HbF measurement, F cells will be measured at baseline, 6 months, and 12 months
measure: Gene Expression Patterns of Study Participants
time frame: 6 Months after initial Hydroxyurea therapy
description: The epigenomic signature and gene expression patterns of study participants receiving hydroxyurea therapy at MTD. MTD is defined as a stable dose without any dose increases (except to account for weight gain), holds, or decreases within 8 weeks with laboratory criteria within the target range. This outcome will explain the mechanisms that yield high HbF responses.
arm group label: Standard Arm
arm group type: Active Comparator
description: Participants randomized to the standard arm will receive a starting dose of hydroxyurea of 20 mg/kg/day.
arm group label: Alternative Arm
arm group type: Experimental
description: Participants randomized to the alternative arm will receive a pharmacokinetic guided starting dose of hydroxyurea based on PK labs drawn at a baseline visit to target an area under the curve (AUC) of 115 mg*h/L in an attempt to approximate maximum tolerated dose (MTD). This dose will not exceed the maximum tolerated dose of 35 mg/kg/day.
intervention type: Drug
intervention name: Hydroxyurea
description: The alternative arm will use PK data to choose a starting hydroxyurea dose to achieve an AUC of 115 mg*h/L to approximate maximum tolerated dose. On the standard arm, participants will start at the traditional, weight-based dose of 20 mg/kg/day. Following selection of the starting dose, all participants will follow the same dose escalation and laboratory monitoring procedures.
arm group label: Alternative Arm
arm group label: Standard Arm
criteria: 
gender: All
minimum age: 6 Months
maximum age: 21 Years
healthy volunteers: No
last name: Patrick Niss, MD
role: Principal Investigator
affiliation: Lifespan
last name: Patrick McGann, MD
phone: 513-736-2246
email: PMcGann@Lifespan.org
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Anemia
mesh term: Anemia, Sickle Cell
mesh term: Hydroxyurea