<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/NCT01715779</url>
  </required_header>
  <id_info>
    <org_study_id>116951</org_study_id>
    <secondary_id>WWE116951</secondary_id>
    <secondary_id>EPI40685</secondary_id>
    <nct_id>NCT01715779</nct_id>
  </id_info>
  <brief_title>Follow-up Study of Patients Who Experienced Thromboembolic Events in the ENABLE Studies</brief_title>
  <official_title>An Observational Follow-up Study of Patients Who Experienced Thromboembolic Events in the ENABLE Studies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this observational study is to characterize long-term (5 years post event)&#xD;
      clinical outcomes in patients who experienced a thromboembolic event (TEE) during&#xD;
      participation in the GSK ENABLE clinical trials.&#xD;
&#xD;
      Patients eligible for the study are patient who experienced a TEE during participation in the&#xD;
      ENABLE trials. Each included patient will be followed for a period of 5 years from the date&#xD;
      of their first TEE. Demographic and clinical characteristics will be collected for the index&#xD;
      date (time of TEE) and every sixth month during the follow-up period, information will be&#xD;
      collected for the outcomes of interests: mortality, new TEE, hepatic decompensation,&#xD;
      evaluation for liver transplant and result of evaluation, and liver transplantation.&#xD;
&#xD;
      All information will collected by medical record review.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Mortality. Patients who experience a thromboembolic event (TEE) and died during study participation.</measure>
    <time_frame>The patients will be followed from 5 years from first occurrence of thromboembolic event.</time_frame>
    <description>An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>New Thromboembolic Events (TEE). Patients who experienced a new TEE during participation.</measure>
    <time_frame>The patients will be followed from 5 years from first occurrence of thromboembolic event.</time_frame>
    <description>An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hepatic decompensation. Patients who experienced a hepatic decompensation during study participation.</measure>
    <time_frame>The patients will be followed from 5 years from first occurrence of thromboembolic event.</time_frame>
    <description>An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation for liver transplant and result of evaluation.</measure>
    <time_frame>The patients will be followed from 5 years from first occurrence of thromboembolic event.</time_frame>
    <description>An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Liver transplantation. Patients who experienced a Liver transplantation during study participation.</measure>
    <time_frame>The patients will be followed from 5 years from first occurrence of thromboembolic event.</time_frame>
    <description>An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">22</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Patients who experienced a thromboembolic event</arm_group_label>
    <description>Patients who experienced a thromboembolic event during participation in the ENABLE clinical trials.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eltrombopag</intervention_name>
    <description>Eltrombopag exposure</description>
    <arm_group_label>Patients who experienced a thromboembolic event</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients under study are patients who experienced a thromboembolic event during&#xD;
        participation in the ENABLE clinical trials.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with portal vein thrombosis (PVT)&#xD;
&#xD;
          -  Patients with deep vein thrombosis (DVT)&#xD;
&#xD;
          -  Patients with pulmonary embolism (PE)&#xD;
&#xD;
          -  Patients with myocardial infarction (MI)&#xD;
&#xD;
          -  Patients with unstable angina&#xD;
&#xD;
          -  Patients with transient ischemic attack (TIA)&#xD;
&#xD;
          -  Patients with ischemic stroke&#xD;
&#xD;
          -  Patients with other TEE including embolism, thrombosis, phlebitis, and&#xD;
             thrombophlebitis at other locations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There are no exclusion criteria for this study&#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>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>April 6, 2016</last_update_submitted>
  <last_update_submitted_qc>April 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Liver transplantation</keyword>
  <keyword>ENABLE</keyword>
  <keyword>observational</keyword>
  <keyword>mortality</keyword>
  <keyword>Thromboembolic Events</keyword>
  <keyword>Hepatic decompensation</keyword>
  <keyword>Long-Term follow-up</keyword>
  <keyword>TEE</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
  </condition_browse>
  <!-- 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/NCT01715779
org study id: 116951
secondary id: WWE116951
secondary id: EPI40685
nct id: NCT01715779
lead sponsor: 
has dmc: No
The objective of this observational study is to characterize long-term (5 years post event)
      clinical outcomes in patients who experienced a thromboembolic event (TEE) during
      participation in the GSK ENABLE clinical trials.

      Patients eligible for the study are patient who experienced a TEE during participation in the
      ENABLE trials. Each included patient will be followed for a period of 5 years from the date
      of their first TEE. Demographic and clinical characteristics will be collected for the index
      date (time of TEE) and every sixth month during the follow-up period, information will be
      collected for the outcomes of interests: mortality, new TEE, hepatic decompensation,
      evaluation for liver transplant and result of evaluation, and liver transplantation.

      All information will collected by medical record review.
observational model: Cohort
time perspective: Prospective
measure: Mortality. Patients who experience a thromboembolic event (TEE) and died during study participation.
time frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
description: An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
measure: New Thromboembolic Events (TEE). Patients who experienced a new TEE during participation.
time frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
description: An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
measure: Hepatic decompensation. Patients who experienced a hepatic decompensation during study participation.
time frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
description: An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
measure: Evaluation for liver transplant and result of evaluation.
time frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
description: An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
measure: Liver transplantation. Patients who experienced a Liver transplantation during study participation.
time frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
description: An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
arm group label: Patients who experienced a thromboembolic event
description: Patients who experienced a thromboembolic event during participation in the ENABLE clinical trials.
intervention type: Drug
intervention name: Eltrombopag
description: Eltrombopag exposure
arm group label: Patients who experienced a thromboembolic event
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
responsible party type: Sponsor
mesh term: Hepatitis C
mesh term: Thromboembolism