<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/NCT03803410</url>
  </required_header>
  <id_info>
    <org_study_id>KMUHIRB-E(I)-20180325</org_study_id>
    <nct_id>NCT03803410</nct_id>
  </id_info>
  <brief_title>Surveillance of HCV in Uremics and Linking to Medical Care</brief_title>
  <official_title>Comprehensive Surveillance of HCV Infecion in Uremics Under Maintenance Hemodialysis and Linking to Medical Care in Taiwan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaohsiung Medical University Chung-Ho Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaohsiung Medical University Chung-Ho Memorial Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      HCV remains to prevail in the uremic patients under hemodialysis. The comprehensive&#xD;
      surveillance in the risk population facilitates the link to care for HCV eradication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Taiwan has the leading prevalence and incidence of end-stage renal disease (ESRD)&#xD;
           worldwide. Uremic patients on maintenance hemodialysis (HD) are at great risk for&#xD;
           hepatitis C virus (HCV) infection. The prevalence and annual incidence of HCV infection&#xD;
           in ESRD patients undergoing hemodialysis have been reported to be 10%-59% and 0.2%-6.2%,&#xD;
           respectively.&#xD;
&#xD;
        2. HCV-related morbidities and mortality remain the major disease burden in the ESRD&#xD;
           population. Uremic patients with HCV infection are associated with higher risk of excess&#xD;
           risk of cardiovascular disease, hospitalization, worse quality of life, and mortality,&#xD;
           and have more profound anemia compared to those without HCV infection..&#xD;
&#xD;
        3. Imperatively, uremic patients remain at high risk of HCV new- or re-infection in the&#xD;
           hemodialysis units.&#xD;
&#xD;
        4. The investigators have performed a surveillance for prevalence of viral hepatitis in a&#xD;
           collaborative group of Nephrologists and Hepatologists, the FORMOSA-LIKE group, which&#xD;
           showed that the proportion of anti-HCV seropositivity in uremic patients is 15-19 % with&#xD;
           the viremic rate of ~75% in Southern Taiwan in 2012. However, the update seroprevalence&#xD;
           and disease severity of HCV infection among the uremic patients in the era of DAA in&#xD;
           Taiwan is unknown. The current study aims to fully execute the surveillance program&#xD;
           among the uremic population&#xD;
&#xD;
        5. Participants with HCV infection will be directly linked to medical care without gap. The&#xD;
           concept of micro-elimination in the high risk environment would help to facilitate WHO&#xD;
           goal of HCV elimination by 2030.&#xD;
&#xD;
        6. Understanding the potential drug-drug interaction (DDI) between directly acting&#xD;
           antivirals (DAA) and co-medications for co-morbidities among uremic patients under&#xD;
           maintenance hemodialysis would be helpful for decision-making when linking to care.&#xD;
&#xD;
        7. Comprehensive surveillance and link-to-care among hemodialysis units might have great&#xD;
           impact on the improvement of both liver-related (biochemical and virological responses,&#xD;
           and hepatic fibrosis regression) and non-liver related outcomes (monthly erythropoietin&#xD;
           requirement and quality of life), and the transfer rate of clean zoning among&#xD;
           HCV-viremic patients.&#xD;
&#xD;
      All uremic participants will be tested for anti-HCV antibody. HCV virology including viral&#xD;
      loads (and genotypes if RNA seropositivity) will be further tested in patients with anti-HCV&#xD;
      seropositivity. All infected subjects will be evaluated for the liver fibrosis by&#xD;
      non-invasive methods including fibroscan, FIB-4 and APRI and Serum WFA(+) -M2BP. All&#xD;
      participants with chronic hepatitis C infection will be directly referred to the&#xD;
      collaborative Hepatology Departments in one medical center and 5 regional core hospitals for&#xD;
      HCV treatment. The outcome of HCV-related diseases, in terms of proportion of HCV&#xD;
      micro-elimination in HD facilities, liver-related outcomes (biochemistry improvement [ ALT&#xD;
      and AFP decline], sustained virological response rate, and hepatic fibrosis regression) and&#xD;
      non-liver related outcomes [monthly erythropoietin requirement, and quality of life [SF36,&#xD;
      HCV-CLDQ] ) will be evaluated 2 years after executing link-to-care strategy.&#xD;
&#xD;
      Year 1: Universal screen, confirmative determination of HCV viremia, genotyping and disease&#xD;
      staging, education and link-to-care for HCV treatment in FORMOSA-LIKE collaborative alliances&#xD;
      Year 2,3: Re-evaluate liver and non-liver related outcomes, and rate of HCV clean zoning&#xD;
      among hemodialysis units.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">May 20, 2022</completion_date>
  <primary_completion_date type="Actual">May 20, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>HCV prevalence</measure>
    <time_frame>36 months</time_frame>
    <description>To explore the current prevalence rate of hepatitis C virus (HCV) infection in uremic patients under maintenance hemodialysis in Taiwan</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>liver fibrosis in HCV uremic patients</measure>
    <time_frame>36 months</time_frame>
    <description>To identify the severity of liver diseases in the uremic patients under maintenance hemodialysis by transient elastography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with potential drug-drug interaction with DAA</measure>
    <time_frame>36 months</time_frame>
    <description>To evaluate the patient number of potential drug-drug interactions (DDI) of co-medications with DAA by checking-up through the website, https://www.hep-druginteractions.org/</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with hepatic outcome after HCV eradication</measure>
    <time_frame>36 months</time_frame>
    <description>incidence of HCC and fibrosis regression by Fibroscan after link-to-care to antiviral therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with extra-hepatic outcome after HCV eradication</measure>
    <time_frame>36 months</time_frame>
    <description>patients with improvement of quality of life by questionnaire SF36 and HCV-CLDQ</description>
  </secondary_outcome>
  <enrollment type="Actual">2973</enrollment>
  <condition>Hepatitis C</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>blood test, noninvasive test for liver fibrosis</intervention_name>
    <description>blood test of HCV serology and virology.noninvasive test including M2BPGi and fibroscan for liver fibrosis</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The FORMOSA-LIKE group is a collaborative alliance of Hepatology and Nephrology in Taiwan.&#xD;
        It contains around 2000 uremic patients with maintenance hemodialysis in 21 hemodialysis&#xD;
        units (one medical center, 4 regional core hospitals and 16 regional clinics). The current&#xD;
        study plan to launch a universal surveillance of HCV in the cohort.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        all uremic patients and medical staffs in the hemodialysis centers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who refuse consents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming-Lung Yu, MD.,PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaohsiung Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaohsiung Medical University Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>807</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>May 26, 2022</last_update_submitted>
  <last_update_submitted_qc>May 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</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>Hepatitis C</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03803410
org study id: KMUHIRB-E(I)-20180325
nct id: NCT03803410
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
HCV remains to prevail in the uremic patients under hemodialysis. The comprehensive
      surveillance in the risk population facilitates the link to care for HCV eradication.
1. Taiwan has the leading prevalence and incidence of end-stage renal disease (ESRD)
           worldwide. Uremic patients on maintenance hemodialysis (HD) are at great risk for
           hepatitis C virus (HCV) infection. The prevalence and annual incidence of HCV infection
           in ESRD patients undergoing hemodialysis have been reported to be 10%-59% and 0.2%-6.2%,
           respectively.

        2. HCV-related morbidities and mortality remain the major disease burden in the ESRD
           population. Uremic patients with HCV infection are associated with higher risk of excess
           risk of cardiovascular disease, hospitalization, worse quality of life, and mortality,
           and have more profound anemia compared to those without HCV infection..

        3. Imperatively, uremic patients remain at high risk of HCV new- or re-infection in the
           hemodialysis units.

        4. The investigators have performed a surveillance for prevalence of viral hepatitis in a
           collaborative group of Nephrologists and Hepatologists, the FORMOSA-LIKE group, which
           showed that the proportion of anti-HCV seropositivity in uremic patients is 15-19 % with
           the viremic rate of ~75% in Southern Taiwan in 2012. However, the update seroprevalence
           and disease severity of HCV infection among the uremic patients in the era of DAA in
           Taiwan is unknown. The current study aims to fully execute the surveillance program
           among the uremic population

        5. Participants with HCV infection will be directly linked to medical care without gap. The
           concept of micro-elimination in the high risk environment would help to facilitate WHO
           goal of HCV elimination by 2030.

        6. Understanding the potential drug-drug interaction (DDI) between directly acting
           antivirals (DAA) and co-medications for co-morbidities among uremic patients under
           maintenance hemodialysis would be helpful for decision-making when linking to care.

        7. Comprehensive surveillance and link-to-care among hemodialysis units might have great
           impact on the improvement of both liver-related (biochemical and virological responses,
           and hepatic fibrosis regression) and non-liver related outcomes (monthly erythropoietin
           requirement and quality of life), and the transfer rate of clean zoning among
           HCV-viremic patients.

      All uremic participants will be tested for anti-HCV antibody. HCV virology including viral
      loads (and genotypes if RNA seropositivity) will be further tested in patients with anti-HCV
      seropositivity. All infected subjects will be evaluated for the liver fibrosis by
      non-invasive methods including fibroscan, FIB-4 and APRI and Serum WFA(+) -M2BP. All
      participants with chronic hepatitis C infection will be directly referred to the
      collaborative Hepatology Departments in one medical center and 5 regional core hospitals for
      HCV treatment. The outcome of HCV-related diseases, in terms of proportion of HCV
      micro-elimination in HD facilities, liver-related outcomes (biochemistry improvement [ ALT
      and AFP decline], sustained virological response rate, and hepatic fibrosis regression) and
      non-liver related outcomes [monthly erythropoietin requirement, and quality of life [SF36,
      HCV-CLDQ] ) will be evaluated 2 years after executing link-to-care strategy.

      Year 1: Universal screen, confirmative determination of HCV viremia, genotyping and disease
      staging, education and link-to-care for HCV treatment in FORMOSA-LIKE collaborative alliances
      Year 2,3: Re-evaluate liver and non-liver related outcomes, and rate of HCV clean zoning
      among hemodialysis units.
observational model: Cohort
time perspective: Prospective
measure: HCV prevalence
time frame: 36 months
description: To explore the current prevalence rate of hepatitis C virus (HCV) infection in uremic patients under maintenance hemodialysis in Taiwan
measure: liver fibrosis in HCV uremic patients
time frame: 36 months
description: To identify the severity of liver diseases in the uremic patients under maintenance hemodialysis by transient elastography
measure: Number of participants with potential drug-drug interaction with DAA
time frame: 36 months
description: To evaluate the patient number of potential drug-drug interactions (DDI) of co-medications with DAA by checking-up through the website, https://www.hep-druginteractions.org/
measure: Number of participants with hepatic outcome after HCV eradication
time frame: 36 months
description: incidence of HCC and fibrosis regression by Fibroscan after link-to-care to antiviral therapy
measure: Number of participants with extra-hepatic outcome after HCV eradication
time frame: 36 months
description: patients with improvement of quality of life by questionnaire SF36 and HCV-CLDQ
intervention type: Procedure
intervention name: blood test, noninvasive test for liver fibrosis
description: blood test of HCV serology and virology.noninvasive test including M2BPGi and fibroscan for liver fibrosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ming-Lung Yu, MD.,PhD.
role: Principal Investigator
affiliation: Kaohsiung Medical University
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Hepatitis C
sharing ipd: No