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/NCT05966740</url>
    </required_header>
    <id_info>
      <org_study_id>1160-0309</org_study_id>
      <nct_id>NCT05966740</nct_id>
    </id_info>
    <brief_title>A Study in the United Sates That Looks at the Safety and Effectiveness of Pradaxa Pellets in Children Aged 3 Months to Less Than 12 Years Who Need Treatment of a Blood Clot or Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot</brief_title>
    <official_title>Safety and Effectiveness of Pradaxa Oral Pellet Formulation for Treatment of Acute Venous Thromboembolic Events (VTE) and/or for Risk Reduction of Recurrence of VTE in Pediatric Patients Aged 3 Months to Less Than 12 Years in a Real World Setting: a Prospective Non-interventional Study Conducted in the United States</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boehringer Ingelheim</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Children's Hospital Acquired Thrombosis consortium</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Boehringer Ingelheim</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>
        The main research question of this study is to obtain further safety and effectiveness data&#xD;
        on Pradaxa Pellets in children aged 3 months to less than 12 years in routine clinical&#xD;
        practice setting.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">June 28, 2029</completion_date>
    <primary_completion_date type="Anticipated">June 28, 2029</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>Incidence of any bleeding-related events</measure>
      <time_frame>Up to week 52</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Thrombotic burden at the end of the treatment period vs baseline, i.e. image-based resolution status of the thrombus (complete response, partial response, stable disease, progressive disease)</measure>
      <time_frame>Baseline and up to week 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of any non-contiguous venous thromboembolic events (VTE) while on treatment</measure>
      <time_frame>Up to week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality related to thrombotic or thromboembolic events</measure>
      <time_frame>Up to week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of post-thrombotic syndrome (PTS)</measure>
      <time_frame>Up to week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Recurrence of VTE while on treatment</measure>
      <time_frame>Up to week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of adverse events (AEs)</measure>
      <time_frame>Up to week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of serious adverse events (SAEs)</measure>
      <time_frame>Up to week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frequency of patients who discontinued treatment due to an AE</measure>
      <time_frame>Up to week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of treatment with dabigatran etexilate</measure>
      <time_frame>Up to week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compliance with dabigatran etexilate treatment</measure>
      <time_frame>Up to week 52</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">330</enrollment>
    <condition>Venous Thromboembolism</condition>
    <arm_group>
      <arm_group_label>Pediatric patients with VTE and/or at risk for VTE</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Pediatric patients aged 3 months to less than 12 years, who may be considered for&#xD;
          anticoagulation with Pradaxa Pellets due to venous thromboembolic events (VTE), are usually&#xD;
          treated in neonatology, pediatric general surgery, cardiac surgery or intensive care units.&#xD;
          Pediatric patients with anticoagulation with Pradaxa Pellets for the prevention of&#xD;
          recurrent VTE are usually evaluated by pediatric hematologists in pediatric hematology&#xD;
          units. Any of these patients that are prescribed Pradaxa pellets may be considered for&#xD;
          inclusion into this study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Written informed consent from parents/care givers and patient assent if age&#xD;
               appropriate&#xD;
  &#xD;
            -  Initiation of Pradaxa Pellets administration either as initial or subsequent therapy:&#xD;
  &#xD;
                 -  Treatment of venous thromboembolic events (VTE)&#xD;
  &#xD;
                 -  Treatment to reduce the risk of recurrence of VTE&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participation in any randomized clinical trial or use of investigational product,&#xD;
               participation in any other observational study is not an exclusion&#xD;
  &#xD;
            -  Any contraindications to Pradaxa Pellets according to the US Prescribing Information.&#xD;
  &#xD;
            -  Previous participation in this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Months</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Boehringer Ingelheim</last_name>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </overall_contact>
    <link>
      <url>https://www.mystudywindow.com</url>
      <description>Related Info</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thromboembolism</mesh_term>
      <mesh_term>Venous Thromboembolism</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Once the criteria in section &quot;Time Frame&quot; are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed &quot;Document Sharing Agreement&quot;.&#xD;
  Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.</ipd_time_frame>
      <ipd_access_criteria>For study documents - upon signing of a 'Document Sharing Agreement'.&#xD;
  For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.</ipd_access_criteria>
      <ipd_url>https://www.mystudywindow.com/msw/datasharing</ipd_url>
    </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/NCT05966740
  org study id: 1160-0309
  nct id: NCT05966740
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The main research question of this study is to obtain further safety and effectiveness data
        on Pradaxa Pellets in children aged 3 months to less than 12 years in routine clinical
        practice setting.
  observational model: Cohort
  time perspective: Prospective
  measure: Incidence of any bleeding-related events
  time frame: Up to week 52
  measure: Thrombotic burden at the end of the treatment period vs baseline, i.e. image-based resolution status of the thrombus (complete response, partial response, stable disease, progressive disease)
  time frame: Baseline and up to week 12
  measure: Occurrence of any non-contiguous venous thromboembolic events (VTE) while on treatment
  time frame: Up to week 52
  measure: Mortality related to thrombotic or thromboembolic events
  time frame: Up to week 52
  measure: Occurrence of post-thrombotic syndrome (PTS)
  time frame: Up to week 52
  measure: Recurrence of VTE while on treatment
  time frame: Up to week 52
  measure: Incidence of adverse events (AEs)
  time frame: Up to week 52
  measure: Incidence of serious adverse events (SAEs)
  time frame: Up to week 52
  measure: Frequency of patients who discontinued treatment due to an AE
  time frame: Up to week 52
  measure: Duration of treatment with dabigatran etexilate
  time frame: Up to week 52
  measure: Compliance with dabigatran etexilate treatment
  time frame: Up to week 52
  arm group label: Pediatric patients with VTE and/or at risk for VTE
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 3 Months
  maximum age: 12 Years
  healthy volunteers: No
  last name: Boehringer Ingelheim
  phone: 1-800-243-0127
  email: clintriage.rdg@boehringer-ingelheim.com
  url: https://www.mystudywindow.com
  description: Related Info
  responsible party type: Sponsor
  mesh term: Thromboembolism
  mesh term: Venous Thromboembolism
  sharing ipd: Yes
  ipd description: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
  Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
  ipd access criteria: For study documents - upon signing of a 'Document Sharing Agreement'.
  For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
  ipd url: https://www.mystudywindow.com/msw/datasharing