<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/NCT03755128</url>
  </required_header>
  <id_info>
    <org_study_id>CR109067</org_study_id>
    <secondary_id>MOM-M281-103</secondary_id>
    <nct_id>NCT03755128</nct_id>
  </id_info>
  <brief_title>A Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn</brief_title>
  <official_title>A Multicenter, Prospective Observational Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of the study is to characterize the current standard of care, clinical&#xD;
      course, and outcomes of pregnant women and their offspring at high risk for early onset&#xD;
      severe hemolytic disease of the fetus and newborn (EOS-HDFN).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The outcomes of interest will be assessed from the information collected on the standard of&#xD;
      care treatment for EOS-HDFN in pregnant women and their offspring from current pregnancy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Anticipated">February 27, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 22, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Live Birth at or After Gestational Age (GA) Week 32 Without Intrauterine Transfusion (IUT)</measure>
    <time_frame>GA Week 32 through GA Week 37</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Live Birth</measure>
    <time_frame>Up to approximately GA Week 37</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants at GA Week 24 Without an IUT</measure>
    <time_frame>Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GA at First IUT</measure>
    <time_frame>Up to approximately GA Week 37</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of IUTs Required</measure>
    <time_frame>Up to approximately GA Week 37</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Fetal Hydrops</measure>
    <time_frame>Post-Birth through Age 3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Neonates Requiring Phototherapy</measure>
    <time_frame>Post-Birth through Age 3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Neonates Requiring Exchange Transfusions</measure>
    <time_frame>Post-Birth through Age 3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days of phototherapy required by neonate</measure>
    <time_frame>Post-Birth through Age 3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Neonates Requiring Simple Transfusions in the First 3 Months of Life</measure>
    <time_frame>Post-Birth through Age 3 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Simple Transfusions Required by Neonate in the First 3 Months of Life</measure>
    <time_frame>Post-Birth through Age 3 Months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN)</condition>
  <condition>Erythroblastosis, Fetal</condition>
  <arm_group>
    <arm_group_label>Pregnant women and their offspring from current pregnancy</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No investigational drugs will be administered as part of the study</description>
    <arm_group_label>Pregnant women and their offspring from current pregnancy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants must have an obstetrical history of severe fetal anemia, hydrops, or&#xD;
        stillbirth related to hemolytic disease of the fetus and newborn, have alloantibody titers&#xD;
        for anti-D ≥32 or anti-Kell titers ≥4, and be currently pregnant with an antigen-positive&#xD;
        fetus. Eligible women may enter the study at any time during the current pregnancy prior to&#xD;
        delivery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Pregnant female participants must be ≥18 years of age with an estimated Gestational Age of&#xD;
        ≥ 8 weeks; not currently pregnant with multiples (twins or more); and no other clinically&#xD;
        relevant abnormalities currently or in their history that the Investigator would deem them&#xD;
        ineligible to participate.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liverpool Hospital</name>
      <address>
        <city>Liverpool</city>
        <zip>2170</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Women's Hospital</name>
      <address>
        <city>Parkville</city>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3N1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Sainte Justine</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Justus-Liebig-Universität Gießen, Kinderherzzentrum</name>
      <address>
        <city>Giessen</city>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leiden University Medical Center</name>
      <address>
        <city>Leiden</city>
        <zip>2333 ZA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Clinic I Provincial de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. San Cecilio</name>
      <address>
        <city>Granada</city>
        <zip>18016</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Universitetssjukhuset, Huddinge</name>
      <address>
        <city>Stockholm</city>
        <zip>SE-141 86</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Edgbaston</city>
        <zip>B15 2TG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals NHSFT</name>
      <address>
        <city>London</city>
        <zip>WC1E 6DB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hemolytic disease of the fetus and newborn (HDFN)</keyword>
  <keyword>Erythroblastosis, Fetal</keyword>
  <keyword>Early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN)</keyword>
  <keyword>M281</keyword>
  <keyword>Pregnant Women</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erythroblastosis, Fetal</mesh_term>
    <mesh_term>Hemolysis</mesh_term>
    <mesh_term>Disease Progression</mesh_term>
  </condition_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/NCT03755128
org study id: CR109067
secondary id: MOM-M281-103
nct id: NCT03755128
lead sponsor: 
has dmc: No
is fda regulated device: No
The primary purpose of the study is to characterize the current standard of care, clinical
      course, and outcomes of pregnant women and their offspring at high risk for early onset
      severe hemolytic disease of the fetus and newborn (EOS-HDFN).
The outcomes of interest will be assessed from the information collected on the standard of
      care treatment for EOS-HDFN in pregnant women and their offspring from current pregnancy.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants With Live Birth at or After Gestational Age (GA) Week 32 Without Intrauterine Transfusion (IUT)
time frame: GA Week 32 through GA Week 37
measure: Percentage of Participants With Live Birth
time frame: Up to approximately GA Week 37
measure: Percentage of Participants at GA Week 24 Without an IUT
time frame: Week 24
measure: GA at First IUT
time frame: Up to approximately GA Week 37
measure: Number of IUTs Required
time frame: Up to approximately GA Week 37
measure: Percentage of Participants With Fetal Hydrops
time frame: Post-Birth through Age 3 Months
measure: Percentage of Neonates Requiring Phototherapy
time frame: Post-Birth through Age 3 Months
measure: Percentage of Neonates Requiring Exchange Transfusions
time frame: Post-Birth through Age 3 Months
measure: Number of days of phototherapy required by neonate
time frame: Post-Birth through Age 3 Months
measure: Percentage of Neonates Requiring Simple Transfusions in the First 3 Months of Life
time frame: Post-Birth through Age 3 Months
measure: Number of Simple Transfusions Required by Neonate in the First 3 Months of Life
time frame: Post-Birth through Age 3 Months
arm group label: Pregnant women and their offspring from current pregnancy
intervention type: Other
intervention name: No intervention
description: No investigational drugs will be administered as part of the study
arm group label: Pregnant women and their offspring from current pregnancy
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
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country: Australia
country: Belgium
country: Canada
country: Germany
country: Netherlands
country: Spain
country: Sweden
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Erythroblastosis, Fetal
mesh term: Hemolysis
mesh term: Disease Progression