<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/NCT04457050</url>
  </required_header>
  <id_info>
    <org_study_id>020966</org_study_id>
    <nct_id>NCT04457050</nct_id>
  </id_info>
  <brief_title>Effect of Hepatitis C Clearance on Insulin Resistance</brief_title>
  <official_title>Insulin Resistance and Resistin In Non-Diabetic Patients With Chronic Hepatitis C Before and After Direct-Acting Antiviral Drugs.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic hepatitis C infection has been linked to insulin resistance, which is the essential&#xD;
      component of metabolic syndrome and type 2 diabetes mellitus. Resistin; an adipokine, has&#xD;
      been demonstrated to stimulate the secretion of several inflammatory factors known to play a&#xD;
      role in the induction of insulin resistance. we investigated the changes in insulin&#xD;
      resistance after hepatitis C clearance in the era of direct antivirals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the link between hepatitis C infection and insulin resistance has been established. Insuli&#xD;
      resistance has been linked to poor response to interferon based therapy. recently, direct&#xD;
      acting antiviral drugs are approved for hepatitis C elimination with high potency and safety.&#xD;
      The aim of the study is to: 1. Determine the prevalence of insulin resistance among&#xD;
      non-diabetic patients with chronic HCV infection. 2. Explore the impact of treatment with&#xD;
      DAAs on insulin resistance among chronic HCV infected patients. 3. Investigate the role of&#xD;
      insulin resistance as a potential prognostic factor for the response to DAAs. 4. Explore the&#xD;
      utility of resistin as a potential biomarker IR among HCV infected patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">November 1, 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>Change in the insulin resistance before and after hepatitis C clearance</measure>
    <time_frame>at baseline and 12 weeks after sustained virologic response</time_frame>
    <description>Assess the change in the value of Homeostatic Model Assessment for Insulin resistance (Homeostatic Model Assessment for Insulin Resistance) after hepatitis C treatment by calculating the HOMA-IR for all patients at baseline and the re-calculation at 12 weeks after viral clearance to clarify the impact of hepatitis C treatment by direct antiviral drugs on insulin sensitivity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of insulin resistance among hepatitis C patients</measure>
    <time_frame>at baseline</time_frame>
    <description>Prevalence of insulin resistance among hepatitis C patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustained virologic response</measure>
    <time_frame>at 12 weeks after treatment</time_frame>
    <description>Sustained virologic response</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Insulin Resistance</condition>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Non-Diabetic Hepatitis C infected patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>clinical examination,&#xD;
measurement of weight (Kg), height (meter), and waist circumference (cm).&#xD;
Calculation of the body mass index.&#xD;
Ultrasound abdominal examination.&#xD;
Laboratory Investigations including Complete blood count, Serum aspartate and alanine aminotransferases, serum albumin, serum bilirubin, serum gamma-glutamyl transpeptidase, and international normalization ratio. HCV-RNA quantification before treatment and 12 weeks after the end of therapy.. Serum lipid profile, fasting and post-prandial blood sugar, glycated hemoglobin A1c also included.&#xD;
Treatment of all patients with the available generic direct antivirals in Egypt (sofosbuvir/ledipasvir ± ribavirin or sofosbuvir plus daclatasvir ± ribavirin).&#xD;
Evaluation of insulin resistance using the homeostasis model assessment of insulin resistance before and 12 weeks after end of treatment.&#xD;
measurement of serum levels of resistin before and at 12 weeks after treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sofosbuvir 400 milligram</intervention_name>
    <description>single daily dose of 400 milligrams</description>
    <arm_group_label>Non-Diabetic Hepatitis C infected patients</arm_group_label>
    <other_name>Soflanork 400 milligram</other_name>
    <other_name>Gratisovir 400 milligram</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daclatasvir 60 milligram</intervention_name>
    <description>single daily dose of 60 milligrams for 12 weeks</description>
    <arm_group_label>Non-Diabetic Hepatitis C infected patients</arm_group_label>
    <other_name>Daklanork 60 milligram</other_name>
    <other_name>Daktavira 60 milligram</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin 400 milligram</intervention_name>
    <description>weight based dose, 1200 mg for weight &gt; 75 kilogram, and 1000 milligram if weight &lt; 75 kilograms for 12 weeks</description>
    <arm_group_label>Non-Diabetic Hepatitis C infected patients</arm_group_label>
    <other_name>Riba 400 milligram</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab</intervention_name>
    <description>single daily dose for 12 weeks</description>
    <arm_group_label>Non-Diabetic Hepatitis C infected patients</arm_group_label>
    <other_name>HARVONI</other_name>
    <other_name>Soflanork plus</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hepatitis C treatment-naïve;&#xD;
&#xD;
          -  Non-diabetic patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Seropositivity for hepatitis B virus infection;&#xD;
&#xD;
          -  Diabetes mellitus;&#xD;
&#xD;
          -  Bbody mass index ≥ 30 Kg/M*2;&#xD;
&#xD;
          -  History of alcohol consumption;&#xD;
&#xD;
          -  Endocrinopathies that may affect the glycemic homeostasis;&#xD;
&#xD;
          -  Other known causes of chronic liver disease; Hepatic decompensation [defined as&#xD;
             history of gastrointestinal bleeding (melena and /or hematemesis), jaundice,&#xD;
             coagulopathy, hepatic encephalopathy, and/or ascites]; bleeding diathesis;&#xD;
&#xD;
          -  Connective tissue diseases;&#xD;
&#xD;
          -  Autoimmune diseases;&#xD;
&#xD;
          -  Cardiac, respiratory or renal disease.&#xD;
&#xD;
          -  Patient receiving immuno-modulatory therapy or drugs that affect the blood glucose&#xD;
             levels such as steroids or beta-blockers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Alexandria</city>
        <zip>21521</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>Sameh A. Lashen</investigator_full_name>
    <investigator_title>Associate Professor of Internal Medicine.</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</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>Ribavirin</mesh_term>
    <mesh_term>Sofosbuvir</mesh_term>
    <mesh_term>Ledipasvir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04457050
org study id: 020966
nct id: NCT04457050
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Chronic hepatitis C infection has been linked to insulin resistance, which is the essential
      component of metabolic syndrome and type 2 diabetes mellitus. Resistin; an adipokine, has
      been demonstrated to stimulate the secretion of several inflammatory factors known to play a
      role in the induction of insulin resistance. we investigated the changes in insulin
      resistance after hepatitis C clearance in the era of direct antivirals.
the link between hepatitis C infection and insulin resistance has been established. Insuli
      resistance has been linked to poor response to interferon based therapy. recently, direct
      acting antiviral drugs are approved for hepatitis C elimination with high potency and safety.
      The aim of the study is to: 1. Determine the prevalence of insulin resistance among
      non-diabetic patients with chronic HCV infection. 2. Explore the impact of treatment with
      DAAs on insulin resistance among chronic HCV infected patients. 3. Investigate the role of
      insulin resistance as a potential prognostic factor for the response to DAAs. 4. Explore the
      utility of resistin as a potential biomarker IR among HCV infected patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the insulin resistance before and after hepatitis C clearance
time frame: at baseline and 12 weeks after sustained virologic response
description: Assess the change in the value of Homeostatic Model Assessment for Insulin resistance (Homeostatic Model Assessment for Insulin Resistance) after hepatitis C treatment by calculating the HOMA-IR for all patients at baseline and the re-calculation at 12 weeks after viral clearance to clarify the impact of hepatitis C treatment by direct antiviral drugs on insulin sensitivity.
measure: Prevalence of insulin resistance among hepatitis C patients
time frame: at baseline
description: Prevalence of insulin resistance among hepatitis C patients
measure: Sustained virologic response
time frame: at 12 weeks after treatment
description: Sustained virologic response
arm group label: Non-Diabetic Hepatitis C infected patients
arm group type: Experimental
description: clinical examination,
measurement of weight (Kg), height (meter), and waist circumference (cm).
Calculation of the body mass index.
Ultrasound abdominal examination.
Laboratory Investigations including Complete blood count, Serum aspartate and alanine aminotransferases, serum albumin, serum bilirubin, serum gamma-glutamyl transpeptidase, and international normalization ratio. HCV-RNA quantification before treatment and 12 weeks after the end of therapy.. Serum lipid profile, fasting and post-prandial blood sugar, glycated hemoglobin A1c also included.
Treatment of all patients with the available generic direct antivirals in Egypt (sofosbuvir/ledipasvir ± ribavirin or sofosbuvir plus daclatasvir ± ribavirin).
Evaluation of insulin resistance using the homeostasis model assessment of insulin resistance before and 12 weeks after end of treatment.
measurement of serum levels of resistin before and at 12 weeks after treatment.
intervention type: Drug
intervention name: Sofosbuvir 400 milligram
description: single daily dose of 400 milligrams
arm group label: Non-Diabetic Hepatitis C infected patients
other name: Soflanork 400 milligram
other name: Gratisovir 400 milligram
intervention type: Drug
intervention name: Daclatasvir 60 milligram
description: single daily dose of 60 milligrams for 12 weeks
arm group label: Non-Diabetic Hepatitis C infected patients
other name: Daklanork 60 milligram
other name: Daktavira 60 milligram
intervention type: Drug
intervention name: Ribavirin 400 milligram
description: weight based dose, 1200 mg for weight > 75 kilogram, and 1000 milligram if weight < 75 kilograms for 12 weeks
arm group label: Non-Diabetic Hepatitis C infected patients
other name: Riba 400 milligram
intervention type: Drug
intervention name: Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab
description: single daily dose for 12 weeks
arm group label: Non-Diabetic Hepatitis C infected patients
other name: HARVONI
other name: Soflanork plus
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: Sameh A. Lashen
investigator title: Associate Professor of Internal Medicine.
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Insulin Resistance
mesh term: Ribavirin
mesh term: Sofosbuvir
mesh term: Ledipasvir
sharing ipd: No