<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/NCT02253550</url>
  </required_header>
  <id_info>
    <org_study_id>TMC435HPC2012</org_study_id>
    <nct_id>NCT02253550</nct_id>
  </id_info>
  <brief_title>Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection</brief_title>
  <official_title>A Phase 2, Open-Label Study to Investigate the Efficacy and Safety of an 8-Week and 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Subjects With Chronic Genotype 4 Hepatitis C Virus Infection With and Without Cirrhosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peter J. Ruane, M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Scientific Affairs, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Peter J. Ruane, M.D., Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will look at the safety and efficacy of 8 week and 12 week treatment with&#xD;
      Sofosbuvir and Simeprevir in treatment-naïve and treatment-experienced patients with chronic&#xD;
      hepatitis C genotype 4.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with confirmed absence of cirrhosis will receive 8 weeks of treatment with&#xD;
      Sofosbuvir and Simeprevir. Patients with confirmed presence of cirrhosis will receive 12&#xD;
      weeks of treatment with Sofosbuvir and Simeprevir. All patients will followed for 24 weeks&#xD;
      post-treatment. Presence or absence of cirrhosis will be evaluated by FibroScan if no&#xD;
      historical liver biopsy or FibroScan is available.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sustained Virologic Response 12 Weeks after Treatment Completion (SVR12)</measure>
    <time_frame>12 weeks post-treatment</time_frame>
    <description>HCV RNA will be measured 12 weeks post-treatment to evaluate SVR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sustained Virologic Response 4 and 24 Weeks after Treatment Completion</measure>
    <time_frame>4 and 24 weeks post-treatment</time_frame>
    <description>HCV RNA will be measured 4 and 24 weeks post-treatment to evaluate SVR</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Chronic Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Cirrhosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with confirmed presence of cirrhosis will received 12 weeks of treatment with Sofosbuvir and Simeprevir</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Cirrhotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with confirmed absence of cirrhosis will received 8 weeks of treatment with Sofosbuvir and Simeprevir</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Simeprevir</intervention_name>
    <description>Simeprevir is a Hepatitis C Virus (HCV) NS3/4A protease inhibitor approved in the United States, Canada and Japan for the treatment of chronic HCV infection.</description>
    <arm_group_label>Cirrhosis</arm_group_label>
    <arm_group_label>Non-Cirrhotic</arm_group_label>
    <other_name>Olysio; TMC435</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sofosbuvir</intervention_name>
    <description>Sofosbuvir is a nucleotide NS5B polymerase inhibitor developed by Gilead Sciences Inc. and approved for the treatment of chronic HCV infection.</description>
    <arm_group_label>Cirrhosis</arm_group_label>
    <arm_group_label>Non-Cirrhotic</arm_group_label>
    <other_name>Sovaldi; GS-7977; PSI-7977</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HCV genotype 4 infection&#xD;
&#xD;
          -  HCV RNA &gt;10,000 IU/mL at screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of clinical hepatic decompensation (history or current evidence of ascites,&#xD;
             bleeding varices or hepatic encephalopathy).&#xD;
&#xD;
          -  Any liver disease of non-HCV etiology. This includes, but is not limited to, acute&#xD;
             hepatitis A, drug- or alcohol-related liver disease, autoimmune hepatitis,&#xD;
             hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic&#xD;
             steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease&#xD;
             considered clinically significant by the investigator.&#xD;
&#xD;
          -  Infection/co-infection with HCV non-genotype 4.&#xD;
&#xD;
          -  Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2)&#xD;
             (positive HIV-1 or HIV-2 antibodies test at screening).&#xD;
&#xD;
          -  Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen [HBsAg] positive).&#xD;
&#xD;
          -  Presence of significant co-morbidities or conditions that would compromise the&#xD;
             subject's safety and could interfere with the subject's participation for the full&#xD;
             duration of the study in the opinion of the investigator&#xD;
&#xD;
          -  Previously been treated with any direct acting anti-HCV agent (approved or&#xD;
             investigational) for chronic HCV infection.&#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>Peter J Ruane, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peter J. Ruane, MD, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peter J. Ruane, MD, Inc.</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>February 22, 2016</last_update_submitted>
  <last_update_submitted_qc>February 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peter J. Ruane, M.D., Inc.</investigator_affiliation>
    <investigator_full_name>Peter J. Ruane, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator, President</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>Virus Diseases</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sofosbuvir</mesh_term>
    <mesh_term>Simeprevir</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/NCT02253550
org study id: TMC435HPC2012
nct id: NCT02253550
lead sponsor: 
collaborator: 
has dmc: No
This study will look at the safety and efficacy of 8 week and 12 week treatment with
      Sofosbuvir and Simeprevir in treatment-naïve and treatment-experienced patients with chronic
      hepatitis C genotype 4.
Patients with confirmed absence of cirrhosis will receive 8 weeks of treatment with
      Sofosbuvir and Simeprevir. Patients with confirmed presence of cirrhosis will receive 12
      weeks of treatment with Sofosbuvir and Simeprevir. All patients will followed for 24 weeks
      post-treatment. Presence or absence of cirrhosis will be evaluated by FibroScan if no
      historical liver biopsy or FibroScan is available.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Sustained Virologic Response 12 Weeks after Treatment Completion (SVR12)
time frame: 12 weeks post-treatment
description: HCV RNA will be measured 12 weeks post-treatment to evaluate SVR
measure: Sustained Virologic Response 4 and 24 Weeks after Treatment Completion
time frame: 4 and 24 weeks post-treatment
description: HCV RNA will be measured 4 and 24 weeks post-treatment to evaluate SVR
arm group label: Cirrhosis
arm group type: Experimental
description: Patients with confirmed presence of cirrhosis will received 12 weeks of treatment with Sofosbuvir and Simeprevir
arm group label: Non-Cirrhotic
arm group type: Experimental
description: Patients with confirmed absence of cirrhosis will received 8 weeks of treatment with Sofosbuvir and Simeprevir
intervention type: Drug
intervention name: Simeprevir
description: Simeprevir is a Hepatitis C Virus (HCV) NS3/4A protease inhibitor approved in the United States, Canada and Japan for the treatment of chronic HCV infection.
arm group label: Cirrhosis
arm group label: Non-Cirrhotic
other name: Olysio; TMC435
intervention type: Drug
intervention name: Sofosbuvir
description: Sofosbuvir is a nucleotide NS5B polymerase inhibitor developed by Gilead Sciences Inc. and approved for the treatment of chronic HCV infection.
arm group label: Cirrhosis
arm group label: Non-Cirrhotic
other name: Sovaldi; GS-7977; PSI-7977
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter J Ruane, MD
role: Principal Investigator
affiliation: Peter J. Ruane, MD, Inc.
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Peter J. Ruane, M.D., Inc.
investigator full name: Peter J. Ruane, M.D.
investigator title: Principal Investigator, President
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Virus Diseases
mesh term: Hepatitis
mesh term: Sofosbuvir
mesh term: Simeprevir