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/NCT06027450</url>
    </required_header>
    <id_info>
      <org_study_id>APHP230354</org_study_id>
      <nct_id>NCT06027450</nct_id>
    </id_info>
    <brief_title>Good Use of Normal Human ImmunoGlobulins (NHIg): Feasibility of Integrating the Criteria of Hierarchy During of NHIg Dispensations</brief_title>
    <acronym>BUS-IG</acronym>
    <official_title>Bon USage Des ImmunoGlobulines Humaines Normales (IgHN) : Faisabilité de l'intégration Des critères de la hiérarchisation Lors Des Dispensations d'IgHN - BUS-IG</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</source>
    <oversight_info>
      <has_dmc>No</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>
        Supply of Normal Human Immunoglobulins (NHIg) has been in steady tension for almost 15 years&#xD;
        in the world. The scarcity of raw material, manufacturing time by industries, and increase&#xD;
        consumptions are some of the causes. These phenomena has been accentuated for two years in&#xD;
        the context of pandemic.&#xD;
  &#xD;
        Faced these difficulties, the french National Medication Security Agency (ANSM) , in&#xD;
        collaboration with health professionals and patients associations concerned, established a&#xD;
        hierarchy of indications of NHIg to prioritize NHIg for patients without therapeutic&#xD;
        alternative (2013 and 2019). Its use is sometimes complex, particularly in the indications&#xD;
        where the use of NHIg must combine clinico-biological criteria and/or previous treatment&#xD;
        lines.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 1, 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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Number of patients with clinical and biological information in the medical record</measure>
      <time_frame>At inclusion</time_frame>
      <description>For TIP: Khellaf score present dating from less than a week&#xD;
  For CDIP: mention of at least one plasmapheresis since diagnosis and before NHIg prescription&#xD;
  For SID: mention of recent repeated infections (at least 2 infections that lead to hospitalization in the year before starting treatment) and rate of IgG dating from less than 3 months.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Adequacy rate between NHIg indications noted in patients files and ANSM prioritization criteria</measure>
      <time_frame>At inclusion</time_frame>
      <description>For TIP: Ig prescription if Khellaf score &gt;8 dating from less than a week.&#xD;
  For CDIP: Ig prescription if plasmapheresis was executed in first intention&#xD;
  For SID: prescription of Ig if recent repeated infections (at least 2 infections that lead to hospitalization in the year before starting treatment) and rate of IgG dating from less than 3 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients prescribed treatment out of hierarchy</measure>
      <time_frame>At inclusion</time_frame>
      <description>Description of the criteria out of hierarchy, justifying the prescription of NHIg in these 3 authorized indications</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Immunoglobulins</condition>
    <arm_group>
      <arm_group_label>Patients treated with NHIg</arm_group_label>
      <description>Patients treated for one of the following indications :&#xD;
  Thrombopenic Idiopathic Purpura (TIP)&#xD;
  Chronic Demyelinating Inflammatory Polyradiculoneuritis (CDIP)&#xD;
  Secondary immune deficiency (SID)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>NHIg prescription</intervention_name>
      <description>Analysis of NHIg prescription</description>
      <arm_group_label>Patients treated with NHIg</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients treated with NHIg for one of the following 3 indications between 01/10/2021 and&#xD;
          31/12/2021: TIP, CDIP and SID&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients treated with NHIg for one of the following 3 indications between 01/10/2021&#xD;
               and 31/12/2021: TIP, CDIP and SID.&#xD;
  &#xD;
            -  Patients 18 years of age and older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient Objection&#xD;
  &#xD;
            -  Patients treated with NHIg- for another indication&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Laure Deville, Dr</last_name>
      <phone>+33142494292</phone>
      <email>laure.deville@aphp.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jérôme Lambert, Dr</last_name>
      <phone>+33142499742</phone>
      <email>jerome.lambert@u-paris.fr</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT06027450
  org study id: APHP230354
  nct id: NCT06027450
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Supply of Normal Human Immunoglobulins (NHIg) has been in steady tension for almost 15 years
        in the world. The scarcity of raw material, manufacturing time by industries, and increase
        consumptions are some of the causes. These phenomena has been accentuated for two years in
        the context of pandemic.
  
        Faced these difficulties, the french National Medication Security Agency (ANSM) , in
        collaboration with health professionals and patients associations concerned, established a
        hierarchy of indications of NHIg to prioritize NHIg for patients without therapeutic
        alternative (2013 and 2019). Its use is sometimes complex, particularly in the indications
        where the use of NHIg must combine clinico-biological criteria and/or previous treatment
        lines.
  observational model: Cohort
  time perspective: Retrospective
  measure: Number of patients with clinical and biological information in the medical record
  time frame: At inclusion
  description: For TIP: Khellaf score present dating from less than a week
  For CDIP: mention of at least one plasmapheresis since diagnosis and before NHIg prescription
  For SID: mention of recent repeated infections (at least 2 infections that lead to hospitalization in the year before starting treatment) and rate of IgG dating from less than 3 months.
  measure: Adequacy rate between NHIg indications noted in patients files and ANSM prioritization criteria
  time frame: At inclusion
  description: For TIP: Ig prescription if Khellaf score >8 dating from less than a week.
  For CDIP: Ig prescription if plasmapheresis was executed in first intention
  For SID: prescription of Ig if recent repeated infections (at least 2 infections that lead to hospitalization in the year before starting treatment) and rate of IgG dating from less than 3 months.
  measure: Number of patients prescribed treatment out of hierarchy
  time frame: At inclusion
  description: Description of the criteria out of hierarchy, justifying the prescription of NHIg in these 3 authorized indications
  arm group label: Patients treated with NHIg
  description: Patients treated for one of the following indications :
  Thrombopenic Idiopathic Purpura (TIP)
  Chronic Demyelinating Inflammatory Polyradiculoneuritis (CDIP)
  Secondary immune deficiency (SID)
  intervention type: Other
  intervention name: NHIg prescription
  description: Analysis of NHIg prescription
  arm group label: Patients treated with NHIg
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Laure Deville, Dr
  phone: +33142494292
  email: laure.deville@aphp.fr
  last name: Jérôme Lambert, Dr
  phone: +33142499742
  email: jerome.lambert@u-paris.fr
  responsible party type: Sponsor
  sharing ipd: Undecided