<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/NCT03022006</url>
  </required_header>
  <id_info>
    <org_study_id>016-0273</org_study_id>
    <nct_id>NCT03022006</nct_id>
  </id_info>
  <brief_title>Safety and Effect of Elbasvir/Grazoprevir Combination Therapy in Hemodialysis Patients With Chronic Hepatitis C</brief_title>
  <official_title>Safety and Effect of Elbasvir/Grazoprevir Combination Therapy in Hemodialysis Patients With Chronic Hepatitis C</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norte Study Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Norte Study Group</source>
  <brief_summary>
    <textblock>
      The number of hemodialysis patients with chronic renal failure in Japan exceeds 0.3 million&#xD;
      and is showing an increasing trend. The rate of infection with hepatitis C virus (HCV) is&#xD;
      high in hemodialysis patients, and it has been revealed that the prognosis is poorer in&#xD;
      HCV-infected hemodialysis patients compared to uninfected patients; therefore, aggressive&#xD;
      therapeutic intervention is required.Investigator previously reported the efficacy and safety&#xD;
      of a NS5A inhibitor; daclatasvir and a HCV protease inhibitor; asunaprevir combination&#xD;
      therapy for Japanese dialysis patients with genotype 1 HCV infection. However, the duration&#xD;
      of the treatment is 24 week, which is quite longer than current standard 12 week therapy .&#xD;
&#xD;
      elbasvir/grazoprevir combination therapy is oral anti-HCV 12 week therapy without the use of&#xD;
      IFN/ribavirin, and a good therapeutic effect has been reported in Japanese phase II studies .&#xD;
      Of note is that these drugs are metabolized mainly in the liver and thus they can be used in&#xD;
      patients with chronic renal failure. Recently, David Roth et al reported that the efficacy&#xD;
      and safety of elbasvir/grazoprevir combination therapy for patients with hepatitis C virus&#xD;
      genotype 1 infection and stage 4-5 chronic kidney disease. In this report, they revealed that&#xD;
      elbasvir/grazoprevir combination therapy could achieve SVR rate of 99% in the modified full&#xD;
      analysis set.&#xD;
&#xD;
      However, no adequate clinical investigation has been performed in Japan, thus far concerning&#xD;
      the therapeutic effect and safety of elbasvir/grazoprevir combination therapy in Japanese&#xD;
      hemodialysis patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <primary_completion_date type="Anticipated">March 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sustained virologic response (SVR) rate at follow-up week 12.</measure>
    <time_frame>12 week</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Chronic Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Dialysis patients with genotype 1 HCV infection</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>elbasvir/grazoprevir</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>elbasvir, grazoprevir</intervention_name>
    <arm_group_label>Dialysis patients with genotype 1 HCV infection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Patients aged 20 years or older at the time of consent&#xD;
&#xD;
          -  Patients who received an adequate explanation prior to the study and provided written&#xD;
             consent for participation in the study&#xD;
&#xD;
          -  Hemodialysis patients complicated by chronic hepatitis C who have HCV Genotype 1b&#xD;
             infection and do not meet the exclusion criteria listed in the following section&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Patients with a past history of hypersensitivity to HCV protease inhibitors and NS5A&#xD;
             inhibitors&#xD;
&#xD;
          -  Patients with serious liver dysfunction (Child-Pugh Class B or C)&#xD;
&#xD;
          -  Patients with difficult-to-control heart disease (e.g., myocardial infarction, heart&#xD;
             failure, and arrhythmia)&#xD;
&#xD;
          -  Patients who have malignant tumors, including hepatoma, at the start of treatment&#xD;
&#xD;
          -  Patients on treatment with drugs listed in the contraindications for coadministration&#xD;
             in the package insert (e.g., some antifungals, some antiepileptics, and human&#xD;
             immunodeficiency virus (HIV) protease inhibitors)&#xD;
&#xD;
          -  Patients with albumin &lt;3.0 g/dL and platelets &lt;75,000 /μL&#xD;
&#xD;
          -  Other patients judged to be inappropriate to participate in the study by the primary&#xD;
             physician&#xD;
&#xD;
          -  Other patients judged to be inappropriate as study subjects by the study manager&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Goki Suda, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norte Study Group</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Naoya Sakamoto, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Norte Study Group</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Goki Suda, Dr.</last_name>
    <phone>011-716-1161</phone>
    <email>gsudgast@pop.med.hokudai.ac.jp</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Naoya Sakamoto, Prof</last_name>
    <phone>011-716-1161</phone>
    <email>sakamoto@med.hokudai.ac.jp</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hokkaido University</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>060-8638</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Goki Suda, Dr</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>April 11, 2017</last_update_submitted>
  <last_update_submitted_qc>April 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Norte Study Group</investigator_affiliation>
    <investigator_full_name>Goki Suda</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <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>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Grazoprevir</mesh_term>
  </intervention_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/NCT03022006
org study id: 016-0273
nct id: NCT03022006
lead sponsor: 
collaborator: 
The number of hemodialysis patients with chronic renal failure in Japan exceeds 0.3 million
      and is showing an increasing trend. The rate of infection with hepatitis C virus (HCV) is
      high in hemodialysis patients, and it has been revealed that the prognosis is poorer in
      HCV-infected hemodialysis patients compared to uninfected patients; therefore, aggressive
      therapeutic intervention is required.Investigator previously reported the efficacy and safety
      of a NS5A inhibitor; daclatasvir and a HCV protease inhibitor; asunaprevir combination
      therapy for Japanese dialysis patients with genotype 1 HCV infection. However, the duration
      of the treatment is 24 week, which is quite longer than current standard 12 week therapy .

      elbasvir/grazoprevir combination therapy is oral anti-HCV 12 week therapy without the use of
      IFN/ribavirin, and a good therapeutic effect has been reported in Japanese phase II studies .
      Of note is that these drugs are metabolized mainly in the liver and thus they can be used in
      patients with chronic renal failure. Recently, David Roth et al reported that the efficacy
      and safety of elbasvir/grazoprevir combination therapy for patients with hepatitis C virus
      genotype 1 infection and stage 4-5 chronic kidney disease. In this report, they revealed that
      elbasvir/grazoprevir combination therapy could achieve SVR rate of 99% in the modified full
      analysis set.

      However, no adequate clinical investigation has been performed in Japan, thus far concerning
      the therapeutic effect and safety of elbasvir/grazoprevir combination therapy in Japanese
      hemodialysis patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Sustained virologic response (SVR) rate at follow-up week 12.
time frame: 12 week
arm group label: Dialysis patients with genotype 1 HCV infection
arm group type: Other
description: elbasvir/grazoprevir
intervention type: Drug
intervention name: elbasvir, grazoprevir
arm group label: Dialysis patients with genotype 1 HCV infection
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Goki Suda, Dr
role: Principal Investigator
affiliation: Norte Study Group
last name: Naoya Sakamoto, Prof
role: Study Director
affiliation: Norte Study Group
last name: Goki Suda, Dr.
phone: 011-716-1161
email: gsudgast@pop.med.hokudai.ac.jp
last name: Naoya Sakamoto, Prof
phone: 011-716-1161
email: sakamoto@med.hokudai.ac.jp
facility: 
status: Recruiting
contact: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Norte Study Group
investigator full name: Goki Suda
investigator title: assistant professor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Grazoprevir