<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/NCT01666249</url>
  </required_header>
  <id_info>
    <org_study_id>IMUPAN1011</org_study_id>
    <secondary_id>Emenda 3.0 - 19/09/2017</secondary_id>
    <nct_id>NCT01666249</nct_id>
  </id_info>
  <brief_title>Clinical Efficacy of Postpartum Immunization of Rh and Coombs Negative Women With Sensitization Risk.</brief_title>
  <official_title>Evaluation of the Clinic Efficacy of Immunoglobulin Anti-RhD KamRho-D® (Panamerican) in Postpartum Immunization of Rh and Coombs Negative Women at Sensitization Risk.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azidus Brasil</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Panamerican Medical Supply</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Azidus Brasil</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This a open, prospective, multicenter, single-arm, phase III study for clinical assessment of&#xD;
      anti-Rh immunoglobulin (KamRho-D®) in Rh and Coombs negative women with risk sensitization.&#xD;
      The anti-Rh immunoglobulin is an immunobiological containing high concentration of specific&#xD;
      antibodies against factor D and &quot;neutralizes&quot; D antigen present in the Rh-positive fetal red&#xD;
      blood cells (Rh +), which passed into the bloodstream of Rh-negative pregnant women (Rh).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This a phase III study in which women participants with RH and Coombs negative will receive&#xD;
      only one dose of 1500 IU anti-Rh immunoglobulin intramuscularly up to 72 hours post&#xD;
      exposition (child-birth) and will be following until six months to verification of negative&#xD;
      Coombs maintenance. Safety evaluation data will include report of all adverse events&#xD;
      (including type, frequency, intensity, seriousness, severity and action taken related to the&#xD;
      investigational product).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Suspended for indetermined period.&#xD;
  </why_stopped>
  <start_date type="Actual">April 2014</start_date>
  <completion_date>December 2020</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Negative result for coombs test up to six months after immunization</measure>
    <time_frame>up to six months</time_frame>
    <description>Will be evaluated by proportion of participants that presented negative result for coombs test until six months after passive immunization with investigational product.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events Report</measure>
    <time_frame>up to six months</time_frame>
    <description>Safety of human immunoglobulin anti-RhD will be verified through adverse events reported by participants throughout study. The adverse events will be classified about the type, frequency, intensity, seriousness, severity and relation to the study drug.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">347</enrollment>
  <condition>Pregnancy; Fetomaternal Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Immunoglobulin Anti-RhD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single intramuscular administration of 300 mcg/2mL, correponding 1500 UI of Human Immunoglobulin Anti-RhD (Kamrho-D - Panamerican), up to 72 hours post exposition (child-birth).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Immunoglobulin Anti-RhD</intervention_name>
    <description>Participants will receive a single intramuscular administration of 300 mcg/2mL, correponding 1500 UI of Human Immunoglobulin Anti-RhD (Kamrho-D - Panamerican), up to 72 hours post exposition (child-birth).</description>
    <arm_group_label>Immunoglobulin Anti-RhD</arm_group_label>
    <other_name>KamRho-D</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Agree to participate, sign and date ICF;&#xD;
&#xD;
          -  18 years old or older;&#xD;
&#xD;
          -  Mothers who are Rh-negative, negative indirect Coombs analyzed by gel agglutination&#xD;
             method, whose just deliveries Rh positive baby.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Be participating simultaneously or have participated in another clinical trial within&#xD;
             the last 12 months;&#xD;
&#xD;
          -  Mothers who are allergic to any components of the formula;&#xD;
&#xD;
          -  Mothers who have a history of IgA deficiency or IgA antibody present;&#xD;
&#xD;
          -  Mothers who have a history of autoimmune hemolytic anemia with hemolysis or with&#xD;
             pre-existing risk of hemolysis;&#xD;
&#xD;
          -  Mothers who have indirect Coombs test positive at the beginning of the treatment;&#xD;
&#xD;
          -  Rh-negative mothers whose delivered Rh-negative babies;&#xD;
&#xD;
          -  Abnormalities of the coagulation system;&#xD;
&#xD;
          -  Patients who made use of vaccines made with live pathogens in the last 03 months or&#xD;
             will make during the study;&#xD;
&#xD;
          -  Patients with clinical diagnosis of prenatal liver and / or severe nephropathy;&#xD;
&#xD;
          -  Principal Investigator of the study criteria.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Regina M Doi, physician</last_name>
    <role>Study Director</role>
    <affiliation>Azidus Brasil Scientific Research and Development Ltda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro de Pesquisa da MEAC - Maternidade Escola Assis Chateaubriand</name>
      <address>
        <city>Fortaleza</city>
        <state>Ceara</state>
        <zip>60430-270</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Tropical de Medicina Reprodutiva e Menopausa -INTRO</name>
      <address>
        <city>Cuiaba</city>
        <state>Mato Grosso</state>
        <zip>78043-306</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associação Educadora São Carlos AESC - Centro de Pesquisa HRPC</name>
      <address>
        <city>Canoas</city>
        <state>Rio Grande Do Sul</state>
        <zip>92425-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital São Lucas (Puc-Rs)</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 25, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>FMH; anti-Rh; efficacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetomaternal Transfusion</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Immunoglobulins, Intravenous</mesh_term>
    <mesh_term>Antibodies</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT01666249
org study id: IMUPAN1011
secondary id: Emenda 3.0 - 19/09/2017
nct id: NCT01666249
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This a open, prospective, multicenter, single-arm, phase III study for clinical assessment of
      anti-Rh immunoglobulin (KamRho-D®) in Rh and Coombs negative women with risk sensitization.
      The anti-Rh immunoglobulin is an immunobiological containing high concentration of specific
      antibodies against factor D and "neutralizes" D antigen present in the Rh-positive fetal red
      blood cells (Rh +), which passed into the bloodstream of Rh-negative pregnant women (Rh).
This a phase III study in which women participants with RH and Coombs negative will receive
      only one dose of 1500 IU anti-Rh immunoglobulin intramuscularly up to 72 hours post
      exposition (child-birth) and will be following until six months to verification of negative
      Coombs maintenance. Safety evaluation data will include report of all adverse events
      (including type, frequency, intensity, seriousness, severity and action taken related to the
      investigational product).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Negative result for coombs test up to six months after immunization
time frame: up to six months
description: Will be evaluated by proportion of participants that presented negative result for coombs test until six months after passive immunization with investigational product.
measure: Adverse Events Report
time frame: up to six months
description: Safety of human immunoglobulin anti-RhD will be verified through adverse events reported by participants throughout study. The adverse events will be classified about the type, frequency, intensity, seriousness, severity and relation to the study drug.
arm group label: Immunoglobulin Anti-RhD
arm group type: Experimental
description: Participants will receive a single intramuscular administration of 300 mcg/2mL, correponding 1500 UI of Human Immunoglobulin Anti-RhD (Kamrho-D - Panamerican), up to 72 hours post exposition (child-birth).
intervention type: Biological
intervention name: Immunoglobulin Anti-RhD
description: Participants will receive a single intramuscular administration of 300 mcg/2mL, correponding 1500 UI of Human Immunoglobulin Anti-RhD (Kamrho-D - Panamerican), up to 72 hours post exposition (child-birth).
arm group label: Immunoglobulin Anti-RhD
other name: KamRho-D
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Regina M Doi, physician
role: Study Director
affiliation: Azidus Brasil Scientific Research and Development Ltda
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Fetomaternal Transfusion
mesh term: Hemorrhage
mesh term: Immunoglobulins
mesh term: Immunoglobulins, Intravenous
mesh term: Antibodies
sharing ipd: Undecided