<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/NCT04460157</url>
  </required_header>
  <id_info>
    <org_study_id>GEHEP-011</org_study_id>
    <nct_id>NCT04460157</nct_id>
  </id_info>
  <brief_title>Prediction of Liver-related Outcomes After HCV Cure</brief_title>
  <official_title>Development of a Predictive Model of Liver Complications Emergence in Patients With Advanced Fibrosis Who Achieve Sustained Virological Response With Direct-acting Antivirals-based Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario de Valme</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto de Salud Carlos III</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitario de Valme</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>
      Objectives: To develop and validate a predictive model, applicable to daily practice, of&#xD;
      liver complications emergence in hepatitis C virus (HCV)-infected patients and advanced&#xD;
      fibrosis, who have achieved sustained viral response (SVR) with direct-acting antivirals&#xD;
      (DAA)-based therapy.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Design: Mulsite prospective multicenter cohort study. Study subjects: HCV-monoinfected and&#xD;
      HIV/HCV-coinfected individuals recruited from two parallel cohorts (GEHEP-MONO Cohort&#xD;
      clinicaltrials.gov ID: NCT02333292(HEPAVIR-DAA Cohort clinicaltrials.gov ID: NCT02057003).&#xD;
      These cohorts enrolled patients with HCV infection, treated with DAA-based regimens after&#xD;
      October 2011, at the units of infectious diseases of 18 hospitals throughout Spain. Patients&#xD;
      who fullfilled the following inclusion criteria are included in this study: 1) Have received&#xD;
      a regimen with one or more DAA; 2) Have achieved SVR 12 weeks after treatment; 3) Have an&#xD;
      evaluable liver stiffness (LS) of more than 9.5 kPa in the three months prior to the start of&#xD;
      treatment.&#xD;
&#xD;
      Follow-up: The baseline time point is the date of SVR. All participants are evaluated by a&#xD;
      common protocol every six months. At every visit, clinical and laboratory examination&#xD;
      focusing on the early detection of liver complications are carried out. LS is assessed by&#xD;
      vibration-controlled transient elastography, according to a standardized procedure, every 12&#xD;
      months. In patients with cirrhosis, liver ultrasound and plasma alpha-fetoprotein&#xD;
      determination are conducted for hepatocellular carcinoma screening, every six months.&#xD;
&#xD;
      Variables and data analysis: The primary outcome variable of the study will be the emergence&#xD;
      of liver complication (hepatic decompensation or hepatocellular carcinoma) or liver&#xD;
      transplant. Predictive models will be develop with clinical, analytical, and genetic&#xD;
      variables independently associated with the primary variable in a Cox regression for&#xD;
      competitive risks applied to a developmental subpopulation. The performance of the model will&#xD;
      be evaluated using COR curves. Sensitivity, specificity, and positive and negative predictive&#xD;
      values will be calculated, both in the developmental population and in a validation&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 2011</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Liver complications emergence</measure>
    <time_frame>From the inclusion until death, liver transplant, HCV reinfection or the censoring date (final study date)</time_frame>
    <description>Appearance of hepatocellular carcinoma, portal hypertensive gastrointestinal bleeding, ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, hepatorrenal syndrome and acute on chronic liver failure after SVR</description>
  </primary_outcome>
  <enrollment type="Anticipated">1035</enrollment>
  <condition>Hepatitis C, Chronic</condition>
  <condition>Sustained Virological Response</condition>
  <condition>Direct-acting Antivirals</condition>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Hepatic Decompensation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        HIV/HCV-coinfected and HCV-monoinfected individuals from two parallel cohorts (HEPAVIR-DAA&#xD;
        Cohort clinicaltrials.gov ID: NCT02057003; GEHEP-MONO Cohort clinicaltrials.gov ID:&#xD;
        NCT02333292). These cohorts enrolled patients with HCV infection, treated with DAA-based&#xD;
        regimens after October 2011, at the units of infectious diseases of 18 hospitals throughout&#xD;
        Spain. Subjects were included if they fulfilled the inclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Had achieved SVR 12 weeks after DAA-based regimen, either with or without&#xD;
             Peg-interferon&#xD;
&#xD;
          -  Showed liver stiffness (LS) value ≥9.5 kPa prior to treatment&#xD;
&#xD;
          -  Had LS measurement available at SVR time-point&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals seropositive for HBsAg&#xD;
&#xD;
          -  Individuals who refuse to participate&#xD;
&#xD;
          -  Individuals under 18 years old&#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_contact>
    <last_name>Anais Corma-Gomez, MD</last_name>
    <phone>955015799</phone>
    <email>anais.corgo@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitario de Valme</name>
      <address>
        <city>Sevilla</city>
        <zip>41014</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ANAIS CORMA-GOMEZ, MD</last_name>
      <phone>0034955015799</phone>
      <email>anais.corgo@gmail.com</email>
    </contact>
    <investigator>
      <last_name>ANAIS CORMA-GOMEZ, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario de Valme</investigator_affiliation>
    <investigator_full_name>Anais Corma-Gomez</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04460157
org study id: GEHEP-011
nct id: NCT04460157
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objectives: To develop and validate a predictive model, applicable to daily practice, of
      liver complications emergence in hepatitis C virus (HCV)-infected patients and advanced
      fibrosis, who have achieved sustained viral response (SVR) with direct-acting antivirals
      (DAA)-based therapy.

      Methods:

      Design: Mulsite prospective multicenter cohort study. Study subjects: HCV-monoinfected and
      HIV/HCV-coinfected individuals recruited from two parallel cohorts (GEHEP-MONO Cohort
      clinicaltrials.gov ID: NCT02333292(HEPAVIR-DAA Cohort clinicaltrials.gov ID: NCT02057003).
      These cohorts enrolled patients with HCV infection, treated with DAA-based regimens after
      October 2011, at the units of infectious diseases of 18 hospitals throughout Spain. Patients
      who fullfilled the following inclusion criteria are included in this study: 1) Have received
      a regimen with one or more DAA; 2) Have achieved SVR 12 weeks after treatment; 3) Have an
      evaluable liver stiffness (LS) of more than 9.5 kPa in the three months prior to the start of
      treatment.

      Follow-up: The baseline time point is the date of SVR. All participants are evaluated by a
      common protocol every six months. At every visit, clinical and laboratory examination
      focusing on the early detection of liver complications are carried out. LS is assessed by
      vibration-controlled transient elastography, according to a standardized procedure, every 12
      months. In patients with cirrhosis, liver ultrasound and plasma alpha-fetoprotein
      determination are conducted for hepatocellular carcinoma screening, every six months.

      Variables and data analysis: The primary outcome variable of the study will be the emergence
      of liver complication (hepatic decompensation or hepatocellular carcinoma) or liver
      transplant. Predictive models will be develop with clinical, analytical, and genetic
      variables independently associated with the primary variable in a Cox regression for
      competitive risks applied to a developmental subpopulation. The performance of the model will
      be evaluated using COR curves. Sensitivity, specificity, and positive and negative predictive
      values will be calculated, both in the developmental population and in a validation
      population.
observational model: Cohort
time perspective: Prospective
measure: Liver complications emergence
time frame: From the inclusion until death, liver transplant, HCV reinfection or the censoring date (final study date)
description: Appearance of hepatocellular carcinoma, portal hypertensive gastrointestinal bleeding, ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, hepatorrenal syndrome and acute on chronic liver failure after SVR
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anais Corma-Gomez, MD
phone: 955015799
email: anais.corgo@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario de Valme
investigator full name: Anais Corma-Gomez
investigator title: Medical Doctor
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
sharing ipd: Undecided