<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/NCT01664845</url>
  </required_header>
  <id_info>
    <org_study_id>VGHKS12-CT3-16</org_study_id>
    <nct_id>NCT01664845</nct_id>
  </id_info>
  <brief_title>Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance</brief_title>
  <official_title>Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaohsiung Veterans General Hospital.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaohsiung Veterans General Hospital.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to investigate the treatment response of metformin, Peg-IFN and&#xD;
      ribavirin combination therapy for chronic hepatitis C virus (HCV).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current standard of treatment for HCV with pegylated interferon(Peg-IFN)-alpha and ribavirin&#xD;
      can achieve sustained virological response (SVR) in only 60-90% of patients. Insulin&#xD;
      resistance is an important factor of non-response to combination therapy. Metformin is a&#xD;
      insulin sensitizer and can effectively reduce insulin resistance. The aim of the study is to&#xD;
      investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy&#xD;
      for chronic HCV.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">August 2014</completion_date>
  <primary_completion_date type="Anticipated">August 2014</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>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 virological response</measure>
    <time_frame>24 weeks after treatment is stopped</time_frame>
    <description>HCV RNA negative 24 weeks after treatment is stopped</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change of HOMA-IR</measure>
    <time_frame>Serial change of HOMA-IR at baseline, 4 weeks and 12 weeks after treatment</time_frame>
    <description>Check Serial change HOMA-IR at baseline, 4 weeks and 12 weeks after treatment</description>
  </secondary_outcome>
  <other_outcome>
    <measure>RVR</measure>
    <time_frame>HCV RNA At 4 weeks</time_frame>
    <description>HCV RNA At 4 weeks</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Chronic Hepatitis c</condition>
  <condition>Insulin Resistance</condition>
  <arm_group>
    <arm_group_label>metformin, pegylated-IFN, ribavirin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>metformin,pegylated-IFN and ribavirin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pegylated-IFN and ribavirin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>pegylated -IFN and ribavirin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>metformin</intervention_name>
    <description>metformin 500mg tid</description>
    <arm_group_label>metformin, pegylated-IFN, ribavirin</arm_group_label>
    <other_name>glucophage</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pegylated-IFN</intervention_name>
    <description>pegasys 180 mcg qw</description>
    <arm_group_label>Pegylated-IFN and ribavirin</arm_group_label>
    <arm_group_label>metformin, pegylated-IFN, ribavirin</arm_group_label>
    <other_name>pegasys</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ribavirin</intervention_name>
    <description>ribavirin 800-1200 mg qd according to BW</description>
    <arm_group_label>Pegylated-IFN and ribavirin</arm_group_label>
    <arm_group_label>metformin, pegylated-IFN, ribavirin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HCV RNA (+) and ALT &gt; 40 U/L&#xD;
&#xD;
          -  Compensated liver&#xD;
&#xD;
          -  HOMA-IR &gt; 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neutrophil &lt;1500/mm3&#xD;
&#xD;
          -  male: Hb &lt; 13 g/dl, female: Hb &lt; 12 g/dl&#xD;
&#xD;
          -  platelet &lt; 80,000 /mm3&#xD;
&#xD;
          -  Cr &gt; 2.5 mg/dl&#xD;
&#xD;
          -  Alcohol use &gt; 20 gm per day&#xD;
&#xD;
          -  uncontrolled depression, thyroid disease, autoimmune disease&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Hepatocellular carcinoma&#xD;
&#xD;
          -  allergy to interferon or ribavirin&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  HBV/HIV co-infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei-Lun Tsai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Gastroenterology, Kaohsoung Veterans General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wei-Lun Tsai, MD</last_name>
    <phone>886-7-3422121</phone>
    <phone_ext>2075</phone_ext>
    <email>tsaiwl@yahoo.com.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kaohsiung Veterans General Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>813</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei-Lun Tsai, MD</last_name>
      <phone>886-7-3422121</phone>
      <phone_ext>2075</phone_ext>
      <email>tsaiwl@yahoo.com.tw</email>
    </contact>
    <investigator>
      <last_name>Wei-Lun Tsai, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>August 13, 2012</last_update_submitted>
  <last_update_submitted_qc>August 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kaohsiung Veterans General Hospital.</investigator_affiliation>
    <investigator_full_name>Wei-Lun Tsai</investigator_full_name>
    <investigator_title>Attending physician</investigator_title>
  </responsible_party>
  <keyword>hepatitis c</keyword>
  <keyword>metformin</keyword>
  <keyword>pegylated interferon</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>Insulin Resistance</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <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/NCT01664845
org study id: VGHKS12-CT3-16
nct id: NCT01664845
lead sponsor: 
has dmc: No
The aim of the study is to investigate the treatment response of metformin, Peg-IFN and
      ribavirin combination therapy for chronic hepatitis C virus (HCV).
Current standard of treatment for HCV with pegylated interferon(Peg-IFN)-alpha and ribavirin
      can achieve sustained virological response (SVR) in only 60-90% of patients. Insulin
      resistance is an important factor of non-response to combination therapy. Metformin is a
      insulin sensitizer and can effectively reduce insulin resistance. The aim of the study is to
      investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy
      for chronic HCV.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: sustained virological response
time frame: 24 weeks after treatment is stopped
description: HCV RNA negative 24 weeks after treatment is stopped
measure: change of HOMA-IR
time frame: Serial change of HOMA-IR at baseline, 4 weeks and 12 weeks after treatment
description: Check Serial change HOMA-IR at baseline, 4 weeks and 12 weeks after treatment
measure: RVR
time frame: HCV RNA At 4 weeks
description: HCV RNA At 4 weeks
arm group label: metformin, pegylated-IFN, ribavirin
arm group type: Active Comparator
description: metformin,pegylated-IFN and ribavirin
arm group label: Pegylated-IFN and ribavirin
arm group type: Placebo Comparator
description: pegylated -IFN and ribavirin
intervention type: Drug
intervention name: metformin
description: metformin 500mg tid
arm group label: metformin, pegylated-IFN, ribavirin
other name: glucophage
intervention type: Drug
intervention name: pegylated-IFN
description: pegasys 180 mcg qw
arm group label: Pegylated-IFN and ribavirin
arm group label: metformin, pegylated-IFN, ribavirin
other name: pegasys
intervention type: Drug
intervention name: ribavirin
description: ribavirin 800-1200 mg qd according to BW
arm group label: Pegylated-IFN and ribavirin
arm group label: metformin, pegylated-IFN, ribavirin
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Wei-Lun Tsai, MD
role: Principal Investigator
affiliation: Department of Gastroenterology, Kaohsoung Veterans General Hospital
last name: Wei-Lun Tsai, MD
phone: 886-7-3422121
phone ext: 2075
email: tsaiwl@yahoo.com.tw
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Kaohsiung Veterans General Hospital.
investigator full name: Wei-Lun Tsai
investigator title: Attending physician
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Insulin Resistance
mesh term: Metformin
mesh term: Ribavirin