<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/NCT01731301</url>
  </required_header>
  <id_info>
    <org_study_id>LIV01</org_study_id>
    <nct_id>NCT01731301</nct_id>
  </id_info>
  <brief_title>A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)</brief_title>
  <official_title>A Pilot Study to Treat Patients With Chronic HCV Genotype 1 and ESRD Receiving Hemodialysis and Naïve to Prior HCV Therapy With Peginterferon Alfa-2b, the Maximally Tolerated Ribavirin Dose and Boceprevir</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liver Institute of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chronic Liver Disease Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Liver Institute of Virginia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. A maximally tolerated dose of ribavirin can be defined in each patient with ESRD&#xD;
           undergoing hemodialysis.&#xD;
&#xD;
        2. Patients with Chronic Hepatitis C Virus (HCV)and End-Stage Renal Disease&#xD;
           (ESRD)undergoing hemodialysis will be able to tolerate and remain on treatment with&#xD;
           peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir.&#xD;
&#xD;
        3. A significant percentage of patients with chronic HCV and ESRD undergoing hemodialysis&#xD;
           can achieve rapid virologic response (RVR), extended virologic response (eRVR) and&#xD;
           sustained virologic response (SVR) when treated with peginterferon alfa-2b, the&#xD;
           maximally tolerated dose of ribavirin and boceprevir.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with ESRD will be treated with a dose escalation of ribavirin starting from 200 mg&#xD;
      everyday (QD) to a maximal tolerated dose. Peginterferon will then be added. Ribavirin will&#xD;
      be dose adjusted as needed. Boceprevir will then be added. Ribavirin will be dose adjusted as&#xD;
      needed. Patients will be monitored for eRVR and SVR. The study end-point is eRVR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">January 2015</completion_date>
  <primary_completion_date type="Anticipated">January 2014</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>Percentage of patients who achieve eRVR at treatment week 28</measure>
    <time_frame>28 weeks</time_frame>
    <description>The primary end-point for evaluation will be the percentage of patients who achieve eRVR at treatment week 28.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tolerability of treatment</measure>
    <time_frame>48 weeks</time_frame>
    <description>A. The ability to define the maximal tolerated dose of ribavirin. B. The ability to remain on peg-interferon alfa-2b, ribavirin and boceprevir for 24 weeks C. The percentage of patients who achieve SVR</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Chronic Hepatitis C</condition>
  <condition>End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Ribavirin, peginterferon, boceprevir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The efficacy and safety of HCV treatment in patients with ESRD will be assessed with a maximal tolerated dose of ribavirin, peginterferon and boceprevir.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin</intervention_name>
    <description>Ribavirin monotherapy will be started at a dose of 100 mg daily. After each successive week the dose of ribavirin will be increased by 100 mg increments daily as long as the hemoglobin remains greater than 10 gm/dl and/or there has not been a decline in the hemoglobin by more than 2 gms/dl from the pretreatment baseline.</description>
    <arm_group_label>Ribavirin, peginterferon, boceprevir</arm_group_label>
    <other_name>Rebetol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Peginterferon</intervention_name>
    <description>After the patient has remained on their maximal tolerated dose of ribavirin for 1 week peginterferon alpha-2b will be initiated at a dose of 1.0 mcg/kg/week. This dose was chosen because it is known to be equivalent in achieving SVR when compared to the 1.5 mcg/kg/dose and is associated with less bone marrow suppression. The dose of ribavirin will be adjusted as needed.</description>
    <arm_group_label>Ribavirin, peginterferon, boceprevir</arm_group_label>
    <other_name>PegIntron, Rebetol and Victrelis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Boceprevir</intervention_name>
    <description>Boceprevir will be added after the patient is on stable doses of ribavirin and peginterferon. The dose of ribavirin will be adjusted as needed.</description>
    <arm_group_label>Ribavirin, peginterferon, boceprevir</arm_group_label>
    <other_name>Victralis</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic HCV defined by:&#xD;
&#xD;
          -  A history of a positive anti-HCV or HCV RNA for &gt; 6 months or&#xD;
&#xD;
          -  A liver biopsy demonstrating at least portal fibrosis&#xD;
&#xD;
          -  HCV genotype 1&#xD;
&#xD;
          -  No prior treatment with any interferon or peginterferon preparation&#xD;
&#xD;
          -  ESRD undergoing hemodialysis for at least 6 months&#xD;
&#xD;
          -  Willingness not to conceive a child during treatment and for 6 months following&#xD;
             discontinuation of treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Histologic evidence of cirrhosis&#xD;
&#xD;
          -  Any co-existent liver disease&#xD;
&#xD;
          -  A platelet count &lt; 90,000&#xD;
&#xD;
          -  A total white blood cell (WBC) &lt; 2.5&#xD;
&#xD;
          -  An absolute neutrophil count &lt; 1.5&#xD;
&#xD;
          -  Hemoglobin &lt; 11 gm/dl on Epoetin-alpha&#xD;
&#xD;
          -  Positive test for anti-HIV&#xD;
&#xD;
          -  Pregnancy of the patient or their intimate partner&#xD;
&#xD;
          -  Women who are breast feeding&#xD;
&#xD;
          -  Significant cardiovascular disease&#xD;
&#xD;
          -  History of suicide intent, severe depression requiring hospitalization or significant&#xD;
             psychiatric disease&#xD;
&#xD;
          -  Malignancy within 5 years of enrollment except for squamous or basal cell skin cancer&#xD;
&#xD;
          -  Co-existent immune disorder such as lupus, rheumatoid as arthritis, colitis, Crohns&#xD;
             disease, sarcoidosis, etc.&#xD;
&#xD;
          -  Any patient in the opinion of the investigator who would not be a satisfactory study&#xD;
             candidate&#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>Mitchell L Shiffman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liver Institute of Virginia, Bon Secours Health System</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mitchell L Shiffman, MD</last_name>
    <phone>804-977-8920</phone>
    <email>mitchell_shiffman@bshsi.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>April G. Long, NP</last_name>
    <phone>804-977-8920</phone>
    <email>april_long@bshsi.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Liver Institute of Virginia</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23226</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Mitchell L Shiffman, MD</last_name>
      <phone>804-977-8920</phone>
      <email>mitchell_shiffman@bshsi.org</email>
    </contact>
    <investigator>
      <last_name>Mitchell L Shiffman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 20, 2012</last_update_submitted>
  <last_update_submitted_qc>November 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic hepatitis C</keyword>
  <keyword>HCV</keyword>
  <keyword>End stage renal disease</keyword>
  <keyword>ESRD</keyword>
  <keyword>Boceprevir</keyword>
  <keyword>Ribavirin</keyword>
  <keyword>Peg-interferon</keyword>
  <keyword>Triple therapy</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>
    <mesh_term>Hepatitis, Chronic</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</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/NCT01731301
org study id: LIV01
nct id: NCT01731301
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
1. A maximally tolerated dose of ribavirin can be defined in each patient with ESRD
           undergoing hemodialysis.

        2. Patients with Chronic Hepatitis C Virus (HCV)and End-Stage Renal Disease
           (ESRD)undergoing hemodialysis will be able to tolerate and remain on treatment with
           peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir.

        3. A significant percentage of patients with chronic HCV and ESRD undergoing hemodialysis
           can achieve rapid virologic response (RVR), extended virologic response (eRVR) and
           sustained virologic response (SVR) when treated with peginterferon alfa-2b, the
           maximally tolerated dose of ribavirin and boceprevir.
Patients with ESRD will be treated with a dose escalation of ribavirin starting from 200 mg
      everyday (QD) to a maximal tolerated dose. Peginterferon will then be added. Ribavirin will
      be dose adjusted as needed. Boceprevir will then be added. Ribavirin will be dose adjusted as
      needed. Patients will be monitored for eRVR and SVR. The study end-point is eRVR.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of patients who achieve eRVR at treatment week 28
time frame: 28 weeks
description: The primary end-point for evaluation will be the percentage of patients who achieve eRVR at treatment week 28.
measure: Tolerability of treatment
time frame: 48 weeks
description: A. The ability to define the maximal tolerated dose of ribavirin. B. The ability to remain on peg-interferon alfa-2b, ribavirin and boceprevir for 24 weeks C. The percentage of patients who achieve SVR
arm group label: Ribavirin, peginterferon, boceprevir
arm group type: Experimental
description: The efficacy and safety of HCV treatment in patients with ESRD will be assessed with a maximal tolerated dose of ribavirin, peginterferon and boceprevir.
intervention type: Drug
intervention name: Ribavirin
description: Ribavirin monotherapy will be started at a dose of 100 mg daily. After each successive week the dose of ribavirin will be increased by 100 mg increments daily as long as the hemoglobin remains greater than 10 gm/dl and/or there has not been a decline in the hemoglobin by more than 2 gms/dl from the pretreatment baseline.
arm group label: Ribavirin, peginterferon, boceprevir
other name: Rebetol
intervention type: Drug
intervention name: Peginterferon
description: After the patient has remained on their maximal tolerated dose of ribavirin for 1 week peginterferon alpha-2b will be initiated at a dose of 1.0 mcg/kg/week. This dose was chosen because it is known to be equivalent in achieving SVR when compared to the 1.5 mcg/kg/dose and is associated with less bone marrow suppression. The dose of ribavirin will be adjusted as needed.
arm group label: Ribavirin, peginterferon, boceprevir
other name: PegIntron, Rebetol and Victrelis
intervention type: Drug
intervention name: Boceprevir
description: Boceprevir will be added after the patient is on stable doses of ribavirin and peginterferon. The dose of ribavirin will be adjusted as needed.
arm group label: Ribavirin, peginterferon, boceprevir
other name: Victralis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mitchell L Shiffman, MD
role: Principal Investigator
affiliation: Liver Institute of Virginia, Bon Secours Health System
last name: Mitchell L Shiffman, MD
phone: 804-977-8920
email: mitchell_shiffman@bshsi.org
last name: April G. Long, NP
phone: 804-977-8920
email: april_long@bshsi.org
facility: 
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Ribavirin