<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/NCT02972723</url>
  </required_header>
  <id_info>
    <org_study_id>10ID003</org_study_id>
    <secondary_id>2010-022850-18</secondary_id>
    <nct_id>NCT02972723</nct_id>
  </id_info>
  <brief_title>Metformin Therapy in HCV Infection</brief_title>
  <official_title>A Study of the Antiviral Activity of Metformin as an Anti-Hepatitis C Virus Agent in Patients With Chronic Hepatitis C Virus Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nottingham University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nottingham University Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hepatitis C virus infection (HCV) is a major cause of cirrhosis and death from liver disease&#xD;
      worldwide. Current therapy for HCV with interferon based therapies results in cure rates of&#xD;
      around 5055% which leaves a significant number of patients without effective therapy. HCV&#xD;
      induces (can bring on) insulin resistance and insulin resistance is a factor known to reduce&#xD;
      the response to antiHCV therapy. This finding stimulated initial studies looking at agents&#xD;
      that may reduce insulin resistance as additional therapy in HCV infection.&#xD;
&#xD;
      A study using metformin in addition to interferon and ribavirin showed a nonsignificant&#xD;
      increase in cure rates (53% vs. 42%), but this was limited to patients with type 1 infection&#xD;
      AND demonstrable insulin resistance. The assumption was made that the potential effect of&#xD;
      metformin was likely to be on insulin resistance and thus by modulating this enhances&#xD;
      response. The investigators (Prof M Harris, University of Leeds) have data (currently&#xD;
      unpublished)suggesting that metformin may have an antiviral effect independent of its effect&#xD;
      on insulin resistance, thus raising the possibility that metformin may have a direct&#xD;
      antiviral effect in vivo. Given that the development of specific antiHCV agents which target&#xD;
      viral proteins such as its polymerase and protease are in trial development but have so far&#xD;
      proved either highly toxic or are likely to have a huge cost there is considerable rationale&#xD;
      for looking at alternative potential antiHCV agents and in this context metformin is cheap,&#xD;
      readily available and has an excellent safety profile. This pilot study therefore addresses&#xD;
      the question &quot;Does metformin therapy result in a significant drop in HCV viral load in&#xD;
      chronically infected patients?&quot;&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">September 2011</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Drop of viral load by at least 1 log in patients receiving Metformin</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Chronic Hepatitis C Infection</condition>
  <arm_group>
    <arm_group_label>Metformin therapy, single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open label trial, participants will be expected to take Metformin twice a day for 2 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>Oral Metformin 1g bd. (total = 2g per day) for 14 days</description>
    <arm_group_label>Metformin therapy, single arm</arm_group_label>
    <other_name>Glucophage</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult Males and Females (18-70 yrs old) able to give consent&#xD;
&#xD;
          -  Chronic hepatitis C virus infection&#xD;
&#xD;
          -  Women of child bearing potential (who have a negative pregnancy test) must agree to&#xD;
             use methods of medically acceptable forms of contraception during the study;&#xD;
             (e.g.intra-uterine device (IUD) or a double-barrier method of oral contraception with&#xD;
             condom)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes.&#xD;
&#xD;
          -  Patients with impaired renal function.&#xD;
&#xD;
          -  Decompensated liver cirrhosis (stable patients with cirrhosis would be eligible).&#xD;
&#xD;
          -  Patients who in the opinion of the Investigator are considered unsuitable.&#xD;
&#xD;
          -  Pregnant females.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen Dr Ryder</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nottingham University Hospitals NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Secondary care Hepatitis clinic at Nottingham University Hospital</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 27, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Metformin Therapy in HCV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <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>Metformin</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/NCT02972723
org study id: 10ID003
secondary id: 2010-022850-18
nct id: NCT02972723
lead sponsor: 
has dmc: Yes
Hepatitis C virus infection (HCV) is a major cause of cirrhosis and death from liver disease
      worldwide. Current therapy for HCV with interferon based therapies results in cure rates of
      around 5055% which leaves a significant number of patients without effective therapy. HCV
      induces (can bring on) insulin resistance and insulin resistance is a factor known to reduce
      the response to antiHCV therapy. This finding stimulated initial studies looking at agents
      that may reduce insulin resistance as additional therapy in HCV infection.

      A study using metformin in addition to interferon and ribavirin showed a nonsignificant
      increase in cure rates (53% vs. 42%), but this was limited to patients with type 1 infection
      AND demonstrable insulin resistance. The assumption was made that the potential effect of
      metformin was likely to be on insulin resistance and thus by modulating this enhances
      response. The investigators (Prof M Harris, University of Leeds) have data (currently
      unpublished)suggesting that metformin may have an antiviral effect independent of its effect
      on insulin resistance, thus raising the possibility that metformin may have a direct
      antiviral effect in vivo. Given that the development of specific antiHCV agents which target
      viral proteins such as its polymerase and protease are in trial development but have so far
      proved either highly toxic or are likely to have a huge cost there is considerable rationale
      for looking at alternative potential antiHCV agents and in this context metformin is cheap,
      readily available and has an excellent safety profile. This pilot study therefore addresses
      the question "Does metformin therapy result in a significant drop in HCV viral load in
      chronically infected patients?"
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Drop of viral load by at least 1 log in patients receiving Metformin
time frame: 14 days
arm group label: Metformin therapy, single arm
arm group type: Experimental
description: Open label trial, participants will be expected to take Metformin twice a day for 2 weeks
intervention type: Drug
intervention name: Metformin
description: Oral Metformin 1g bd. (total = 2g per day) for 14 days
arm group label: Metformin therapy, single arm
other name: Glucophage
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Stephen Dr Ryder
role: Principal Investigator
affiliation: Nottingham University Hospitals NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Metformin