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/NCT06010524</url>
    </required_header>
    <id_info>
      <org_study_id>HEPCTURKEY_2</org_study_id>
      <nct_id>NCT06010524</nct_id>
    </id_info>
    <brief_title>A Study of Chronic Hepatitis C Patients Treated With SOF/VEL/VOX</brief_title>
    <acronym>VOSEVI_Reg</acronym>
    <official_title>A Retrospective Study of Chronic Hepatitis C Patients Treated With SOF/VEL/VOX: Real Life Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cerrahpasa Medical Faculty Foundation</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cerrahpasa Medical Faculty Foundation</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>
        This is a retrospective, non-interventional study. Investigators from infectious diseases and&#xD;
        gastroenterology departments will participate this study.&#xD;
  &#xD;
        Patients data will be collected from hospital medical records.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pangenotypic Sofosbuvir/Velpatasvir/Voxilaprevir for 8-12 weeks has been shown highly&#xD;
        effective, safe, and well-tolerated in treating patients with chronic HCV infection in&#xD;
        clinical trial settings, however, there are no real-world setting data are available.This is&#xD;
        the first opportunity from all over the world to demonstrate SOF/VEL/VOXs efficacy and safety&#xD;
        in Real World setting especially for the naive patients.&#xD;
  &#xD;
        SOF/VEL/VOX is often positioned in retreatment by international guidelines. Previously the&#xD;
        reimbursement guideline in Turkey did not allow patients to be re-treated after the failure&#xD;
        of DAA treatments. With current guideline Vosevi is approved as the only option for failures&#xD;
        of DAA treatments. In the past years in Turkey, SOF+RBV in GT2, SOF+PEF+RBV in GT3, LDV/SOF&#xD;
        in GT1.4-6 patients and Viekirax/Exviera in GT1,4 patients have been used and unfortunately,&#xD;
        some patients did not benefit from these suboptimal treatments. The efficacy and safety of&#xD;
        SOF/VEL/VOX in patients who have experienced treatment failure in real life will be another&#xD;
        objective of the research.&#xD;
  &#xD;
        This research will support&#xD;
  &#xD;
          1. Efficacy and safety of 8-week Pangenotypic SOF/VEL/VOX for treatment naive&#xD;
             non-cirrhotics&#xD;
  &#xD;
          2. Efficacy and safety of 12-week Pangenotypic SOF/VEL/VOX for treatment naive compensate&#xD;
             cirrhotics&#xD;
  &#xD;
          3. Efficacy and safety of 12-week Pangenotypic SOF/VEL/VOX for retreatment of NS5A or NS3A4&#xD;
             and non-NS5A treatment-experienced patients (incl. noncirrhotics and cirrhotics)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>Sustained Virology Response 12</measure>
      <time_frame>From start date of treatment to 12 weeks after the completion of treatment</time_frame>
      <description>Rate of the patients with undetectabled HCVRNA after 12 weeks of the completion of SOF/VEL/VOX treatment</description>
    </primary_outcome>
    <enrollment type="Anticipated">450</enrollment>
    <condition>Hepatitis C</condition>
    <eligibility>
      <study_pop>
        <textblock>
          All CHC patients who received Soforbuvir/Velpatasvir/Voxilaprevir combination therapy will&#xD;
          be included in this study. The information of these patients will be recorded&#xD;
          retrospectively from the Hospital registry system.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients diagnosed as chronic hepatitis C and aged 18 and older&#xD;
  &#xD;
            -  Patients received SOF/VEL/VOX treatment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Decompensated cirrhotic HCV patients&#xD;
  &#xD;
            -  Having HCC&#xD;
  &#xD;
            -  eGFR&lt;30 ml/min&#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>Fehmi Tabak, Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cerrahpasa Medical Faculty</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fehmi Tabak, Prof</last_name>
      <phone>+905322763788</phone>
      <email>fehmitabak@yahoo.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ilker Kurkcu</last_name>
      <phone>+905326354515</phone>
      <email>ilker.kurkcu@sentez-cro.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cerrahpasa Medical Faculty</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fehmi Tabak, Prof</last_name>
        <phone>+905322763788</phone>
        <email>fehmitabak@yahoo.com</email>
      </contact>
      <contact_backup>
        <last_name>ilker kurkcu</last_name>
        <email>ilker.kurkcu@sentez-cro.com</email>
      </contact_backup>
      <investigator>
        <last_name>Fehmi Tabak, Prof</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Hepatitis C</keyword>
    <keyword>VOSEVI</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hepatitis A</mesh_term>
      <mesh_term>Hepatitis C</mesh_term>
      <mesh_term>Hepatitis C, Chronic</mesh_term>
      <mesh_term>Hepatitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06010524
  org study id: HEPCTURKEY_2
  nct id: NCT06010524
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a retrospective, non-interventional study. Investigators from infectious diseases and
        gastroenterology departments will participate this study.
  
        Patients data will be collected from hospital medical records.
  Pangenotypic Sofosbuvir/Velpatasvir/Voxilaprevir for 8-12 weeks has been shown highly
        effective, safe, and well-tolerated in treating patients with chronic HCV infection in
        clinical trial settings, however, there are no real-world setting data are available.This is
        the first opportunity from all over the world to demonstrate SOF/VEL/VOXs efficacy and safety
        in Real World setting especially for the naive patients.
  
        SOF/VEL/VOX is often positioned in retreatment by international guidelines. Previously the
        reimbursement guideline in Turkey did not allow patients to be re-treated after the failure
        of DAA treatments. With current guideline Vosevi is approved as the only option for failures
        of DAA treatments. In the past years in Turkey, SOF+RBV in GT2, SOF+PEF+RBV in GT3, LDV/SOF
        in GT1.4-6 patients and Viekirax/Exviera in GT1,4 patients have been used and unfortunately,
        some patients did not benefit from these suboptimal treatments. The efficacy and safety of
        SOF/VEL/VOX in patients who have experienced treatment failure in real life will be another
        objective of the research.
  
        This research will support
  
          1. Efficacy and safety of 8-week Pangenotypic SOF/VEL/VOX for treatment naive
             non-cirrhotics
  
          2. Efficacy and safety of 12-week Pangenotypic SOF/VEL/VOX for treatment naive compensate
             cirrhotics
  
          3. Efficacy and safety of 12-week Pangenotypic SOF/VEL/VOX for retreatment of NS5A or NS3A4
             and non-NS5A treatment-experienced patients (incl. noncirrhotics and cirrhotics)
  observational model: Cohort
  time perspective: Retrospective
  measure: Sustained Virology Response 12
  time frame: From start date of treatment to 12 weeks after the completion of treatment
  description: Rate of the patients with undetectabled HCVRNA after 12 weeks of the completion of SOF/VEL/VOX treatment
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Fehmi Tabak, Prof
  role: Principal Investigator
  affiliation: Cerrahpasa Medical Faculty
  last name: Fehmi Tabak, Prof
  phone: +905322763788
  email: fehmitabak@yahoo.com
  last name: Ilker Kurkcu
  phone: +905326354515
  email: ilker.kurkcu@sentez-cro.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Turkey
  responsible party type: Sponsor
  mesh term: Hepatitis A
  mesh term: Hepatitis C
  mesh term: Hepatitis C, Chronic
  mesh term: Hepatitis
  sharing ipd: No