xml: <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/NCT06039020</url>
    </required_header>
    <id_info>
      <org_study_id>B5411004</org_study_id>
      <nct_id>NCT06039020</nct_id>
    </id_info>
    <brief_title>ATGAM General Investigation</brief_title>
    <official_title>ATGAM Intravenous Infusion 250mg General Investigation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pfizer</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pfizer</source>
    <brief_summary>
      <textblock>
        The objective of this study is to confirm the safety of ATGAM in patients with moderate to&#xD;
        severe aplastic anemia under the actual use in Japan.&#xD;
  &#xD;
        The registration criteria is patients with moderate to severe aplastic anemia who receive&#xD;
        ATGAM.&#xD;
  &#xD;
        The observation period is 24 weeks (6 months) from the start of administration (Day 1).&#xD;
        However, in cases where treatment has been completed or discontinued less than 24 weeks after&#xD;
        the start of administration, observation is continued until completion (discontinuation) of&#xD;
        treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 28, 2023</start_date>
    <completion_date type="Anticipated">March 12, 2026</completion_date>
    <primary_completion_date type="Anticipated">March 12, 2026</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>Number of participants with adverse drug reactions (ADRs)</measure>
      <time_frame>24 weeks (6 months) from the start of administration (Day 1)</time_frame>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Aplastic Anemia</condition>
    <arm_group>
      <arm_group_label>Anti-human thymocyte immunoglobulin, equine</arm_group_label>
      <description>Patients with moderate to severe aplastic anemia who receive ATGAM (Anti-human thymocyte immunoglobulin, equine)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Anti-human thymocyte immunoglobulin, equine</intervention_name>
      <description>Usually, 40 mg of anti-human thymocyte immunoglobulin, equine per kilogram of body weight should be slowly administered by intravenous drip infusion once daily. The duration of treatment should be 4 days.</description>
      <arm_group_label>Anti-human thymocyte immunoglobulin, equine</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with moderate to severe aplastic anemia who receive ATGAM&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with moderate to severe aplastic anemia who receive ATGAM&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No exclusion criteria is set out in this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pfizer CT.gov Call Center</last_name>
      <role>Study Director</role>
      <affiliation>Pfizer</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pfizer CT.gov Call Center</last_name>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </overall_contact>
    <link>
      <url>https://pmiform.com/clinical-trial-info-request?StudyID=B5411004</url>
      <description>To obtain contact information for a study center near you, click here.</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ATGAM;</keyword>
    <keyword>Anti-human thymocyte immunoglobulin, equine;</keyword>
    <keyword>Aplastic anemia;</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anemia, Aplastic</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>No</sharing_ipd>
      <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06039020
  org study id: B5411004
  nct id: NCT06039020
  lead sponsor: 
  The objective of this study is to confirm the safety of ATGAM in patients with moderate to
        severe aplastic anemia under the actual use in Japan.
  
        The registration criteria is patients with moderate to severe aplastic anemia who receive
        ATGAM.
  
        The observation period is 24 weeks (6 months) from the start of administration (Day 1).
        However, in cases where treatment has been completed or discontinued less than 24 weeks after
        the start of administration, observation is continued until completion (discontinuation) of
        treatment.
  observational model: Cohort
  time perspective: Prospective
  measure: Number of participants with adverse drug reactions (ADRs)
  time frame: 24 weeks (6 months) from the start of administration (Day 1)
  arm group label: Anti-human thymocyte immunoglobulin, equine
  description: Patients with moderate to severe aplastic anemia who receive ATGAM (Anti-human thymocyte immunoglobulin, equine)
  intervention type: Drug
  intervention name: Anti-human thymocyte immunoglobulin, equine
  description: Usually, 40 mg of anti-human thymocyte immunoglobulin, equine per kilogram of body weight should be slowly administered by intravenous drip infusion once daily. The duration of treatment should be 4 days.
  arm group label: Anti-human thymocyte immunoglobulin, equine
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 0 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Pfizer CT.gov Call Center
  role: Study Director
  affiliation: Pfizer
  last name: Pfizer CT.gov Call Center
  phone: 1-800-718-1021
  email: ClinicalTrials.gov_Inquiries@pfizer.com
  url: https://pmiform.com/clinical-trial-info-request?StudyID=B5411004
  description: To obtain contact information for a study center near you, click here.
  responsible party type: Sponsor
  mesh term: Anemia, Aplastic
  mesh term: Immunoglobulins
  mesh term: Immunoglobulins, Intravenous
  mesh term: Antibodies
  sharing ipd: No
  ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.