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/NCT06039124</url>
    </required_header>
    <id_info>
      <org_study_id>69HCL21_1438</org_study_id>
      <nct_id>NCT06039124</nct_id>
    </id_info>
    <brief_title>Subsequent Bevacizumab Treatment in Patients With HHT. Follow up BABH</brief_title>
    <acronym>BEST</acronym>
    <official_title>Subsequent Bevacizumab Treatment in Patients With HHT After the End of BABH Interventional Study. A Descriptive Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospices Civils de Lyon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospices Civils de Lyon</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
    </oversight_info>
    <brief_summary>
      <textblock>
        Bevacizumab is widely prescribed for the treatment of severe bleeding related to epistaxis or&#xD;
        gastrointestinal bleeding in HHT.&#xD;
  &#xD;
        We studied the efficacy of bevacizumab on severe bleeding in HHT patients in a randomized&#xD;
        study recently published (NCT03227263, J Int Med 2023). In this study, 24 patients were&#xD;
        included, 12 patients received bevacizumab and 12 patients received placebo. The duration of&#xD;
        patient participation was 6 months, including the 2.5-month treatment period and 3.5 month&#xD;
        follow-up after treatment.&#xD;
  &#xD;
        We describe the evolution of the number of RBC transfused in HHT patients who received&#xD;
        bevacizumab during the year after the end of the study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 1, 2021</start_date>
    <completion_date type="Actual">August 1, 2022</completion_date>
    <primary_completion_date type="Actual">January 1, 2022</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>Bevacizumab treatment description after end of BABH study</measure>
      <time_frame>12 months</time_frame>
      <description>Number of patients who received bevacizumab after BABH study. Among patients who received bevacizumab in BABH study: description of re-treatments.&#xD;
  In patients who received placebo in BABH study: description of treatments.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">23</enrollment>
    <condition>Hemorrhagic Hereditary Telangiectasia</condition>
    <condition>HHT</condition>
    <arm_group>
      <arm_group_label>HHT patients previously included in BABH study</arm_group_label>
      <description>Clinical and therapeutic follow-up of HHT patients for one year after the end of a clinical trial using bevacizumab.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>bevacizumab treatment</intervention_name>
      <description>Descriptive study of HHT patients (bevacizumab treatment, number of RBC transfused)</description>
      <arm_group_label>HHT patients previously included in BABH study</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients included in the BABH study (adults, with a confirmed diagnosis of Rendu-Osler&#xD;
          disease, presenting with bleeding requiring regular transfusions).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient included in BABH study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients opposition&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sophie DUPUIS-GIROD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospices Civils de Lyon</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers</name>
        <address>
          <city>Angers</city>
          <zip>49933</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hôpital Ambroise Paré</name>
        <address>
          <city>Boulogne Billancourt</city>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>CHU de Montpellier-Hôpital St Eloi</name>
        <address>
          <city>Montpellier</city>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <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>HHT</keyword>
    <keyword>VEGF therapy</keyword>
    <keyword>BEVACIZUMAB</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Telangiectasis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bevacizumab</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06039124
  org study id: 69HCL21_1438
  nct id: NCT06039124
  lead sponsor: 
  has dmc: No
  Bevacizumab is widely prescribed for the treatment of severe bleeding related to epistaxis or
        gastrointestinal bleeding in HHT.
  
        We studied the efficacy of bevacizumab on severe bleeding in HHT patients in a randomized
        study recently published (NCT03227263, J Int Med 2023). In this study, 24 patients were
        included, 12 patients received bevacizumab and 12 patients received placebo. The duration of
        patient participation was 6 months, including the 2.5-month treatment period and 3.5 month
        follow-up after treatment.
  
        We describe the evolution of the number of RBC transfused in HHT patients who received
        bevacizumab during the year after the end of the study.
  observational model: Cohort
  time perspective: Retrospective
  measure: Bevacizumab treatment description after end of BABH study
  time frame: 12 months
  description: Number of patients who received bevacizumab after BABH study. Among patients who received bevacizumab in BABH study: description of re-treatments.
  In patients who received placebo in BABH study: description of treatments.
  arm group label: HHT patients previously included in BABH study
  description: Clinical and therapeutic follow-up of HHT patients for one year after the end of a clinical trial using bevacizumab.
  intervention type: Other
  intervention name: bevacizumab treatment
  description: Descriptive study of HHT patients (bevacizumab treatment, number of RBC transfused)
  arm group label: HHT patients previously included in BABH study
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sophie DUPUIS-GIROD, PhD
  role: Principal Investigator
  affiliation: Hospices Civils de Lyon
  facility: 
  facility: 
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Telangiectasis
  mesh term: Bevacizumab