<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/NCT02992457</url>
  </required_header>
  <id_info>
    <org_study_id>Asem Elfert</org_study_id>
    <nct_id>NCT02992457</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection</brief_title>
  <official_title>Study of the Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With and Without Post-hepatitis C Cirrhosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated&#xD;
      nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in&#xD;
      Egypt. For decades the antiviral therapy of chronic HCV infection was based on the&#xD;
      administration of Interferon(IFN), initially alone and then in combination with Ribavirin&#xD;
      (RBV), but this regimen was effective in only 50% of patients with genotype 1, with&#xD;
      significant side effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated&#xD;
      nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in&#xD;
      Egypt. For decades the antiviral therapy of chronic HCV infection was based on the&#xD;
      administration ofInterferon(IFN), initially alone and then in combination with Ribavirin&#xD;
      (RBV), but this regimen was effective in only 50% of patients with genotype 1, with&#xD;
      significant side effects. The introduction of direct acting antiviral agents, in particular&#xD;
      sofosbuvir (SOF), has revolutionized the treatment for chronic hepatitis C virus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <phase>Phase 4</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>Number of patients with sustained virological response.</measure>
    <time_frame>2 months</time_frame>
    <description>The number of patients achieving SVR</description>
  </primary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">10000</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Sof-Riba</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sofosbuvir ribavirin 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sof- Riba- Pegylated interferon</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sof- Olysio</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sofosbuvir and simeprevir for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sof- Dacla</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sofosbuvir and Daclatasvir for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Harvony</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sofosbuvir and ledipasvir for 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ritaprevir, paritaprevir, ombetasvir</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Querevo for 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Salvage therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>sofosbuvir, daclatasvir, simeprevir,ribavirin or sofosbuvir and querevo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sofosbuvir</intervention_name>
    <description>Sofosbuvir 400 mg daily.</description>
    <arm_group_label>Sof- Dacla</arm_group_label>
    <arm_group_label>Sof- Olysio</arm_group_label>
    <arm_group_label>Sof- Riba- Pegylated interferon</arm_group_label>
    <arm_group_label>Sof-Riba</arm_group_label>
    <other_name>sovaldi , mpiviropack</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin</intervention_name>
    <description>Ribavirin 1000-1200 mg daily</description>
    <arm_group_label>Sof- Riba- Pegylated interferon</arm_group_label>
    <arm_group_label>Sof-Riba</arm_group_label>
    <other_name>Rebetol, Riba</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pegylated-interferon alfa-2a</intervention_name>
    <description>Pegylated interferon alfa-2a once weekly for 3 months</description>
    <arm_group_label>Sof- Riba- Pegylated interferon</arm_group_label>
    <other_name>peginteron, pegasys</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Simeprevir</intervention_name>
    <description>Olysio once daily.</description>
    <arm_group_label>Sof- Olysio</arm_group_label>
    <other_name>Olysio</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daclatasvir</intervention_name>
    <description>Dakla once daily for three months.</description>
    <arm_group_label>Sof- Dacla</arm_group_label>
    <other_name>Daklatasvir, Dakla</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ritaprevir, paritaprevir, ombetasvir</intervention_name>
    <description>Querevo for three months</description>
    <arm_group_label>Ritaprevir, paritaprevir, ombetasvir</arm_group_label>
    <other_name>querevo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sofosbuvir and Ledipasvir</intervention_name>
    <description>Once daily for three months</description>
    <arm_group_label>Harvony</arm_group_label>
    <other_name>Harvony</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salvage therapy</intervention_name>
    <description>three months in repeated treatment failure</description>
    <arm_group_label>Salvage therapy</arm_group_label>
    <other_name>Sofosbuvir,simeprevir, daclatasvir, ribavirin or sofosbuvir and querevo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • HCV infection&#xD;
&#xD;
               -  Adult patients, 18years and older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Child score &gt; 12&#xD;
&#xD;
               -  Severe Renal impairment&#xD;
&#xD;
               -  Pregnant and lactating women&#xD;
&#xD;
               -  HCC or other malignant neoplasms&#xD;
&#xD;
               -  Co-infection with human immunodeficiency virus (HIV)&#xD;
&#xD;
               -  Co-infection with hepatitis B virus (HBV)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asem Elfert, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Tanta university hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lobna Abo ALi, Ass Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Tanta university hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sabry Abou Saif, Ass Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Tanta university hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Taher Eldemerdash, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Tanta University hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hala M Elsabagh, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Tanta University hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed Elkassas, Lecturer</last_name>
    <role>Study Chair</role>
    <affiliation>Helwan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eslam Esmail, Ass Lecturer</last_name>
    <role>Study Chair</role>
    <affiliation>Tanta University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sherief Abd-Elsalam</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tanta University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sherief Abd-Elsalam</name>
      <address>
        <city>Tanta</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tanta university hospital</name>
      <address>
        <city>Tanta</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 10, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>August 23, 2023</last_update_submitted>
  <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Sherief Abd-Elsalam</investigator_full_name>
    <investigator_title>Principle investigator</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interferons</mesh_term>
    <mesh_term>Ribavirin</mesh_term>
    <mesh_term>Interferon-alpha</mesh_term>
    <mesh_term>Interferon alpha-2</mesh_term>
    <mesh_term>Peginterferon alfa-2a</mesh_term>
    <mesh_term>Sofosbuvir</mesh_term>
    <mesh_term>Ledipasvir</mesh_term>
    <mesh_term>Simeprevir</mesh_term>
    <mesh_term>Ledipasvir, sofosbuvir drug combination</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/NCT02992457
org study id: Asem Elfert
nct id: NCT02992457
lead sponsor: 
has dmc: Yes
Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated
      nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in
      Egypt. For decades the antiviral therapy of chronic HCV infection was based on the
      administration of Interferon(IFN), initially alone and then in combination with Ribavirin
      (RBV), but this regimen was effective in only 50% of patients with genotype 1, with
      significant side effects.
Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated
      nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in
      Egypt. For decades the antiviral therapy of chronic HCV infection was based on the
      administration ofInterferon(IFN), initially alone and then in combination with Ribavirin
      (RBV), but this regimen was effective in only 50% of patients with genotype 1, with
      significant side effects. The introduction of direct acting antiviral agents, in particular
      sofosbuvir (SOF), has revolutionized the treatment for chronic hepatitis C virus.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with sustained virological response.
time frame: 2 months
description: The number of patients achieving SVR
arm group label: Sof-Riba
arm group type: Active Comparator
description: Sofosbuvir ribavirin 6 months.
arm group label: Sof- Riba- Pegylated interferon
arm group type: Active Comparator
description: Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a 3 months
arm group label: Sof- Olysio
arm group type: Active Comparator
description: Sofosbuvir and simeprevir for 3 months.
arm group label: Sof- Dacla
arm group type: Active Comparator
description: Sofosbuvir and Daclatasvir for 3 months.
arm group label: Harvony
arm group type: Active Comparator
description: Sofosbuvir and ledipasvir for 3 months
arm group label: Ritaprevir, paritaprevir, ombetasvir
arm group type: Active Comparator
description: Querevo for 3 months
arm group label: Salvage therapy
arm group type: Active Comparator
description: sofosbuvir, daclatasvir, simeprevir,ribavirin or sofosbuvir and querevo
intervention type: Drug
intervention name: Sofosbuvir
description: Sofosbuvir 400 mg daily.
arm group label: Sof- Dacla
arm group label: Sof- Olysio
arm group label: Sof- Riba- Pegylated interferon
arm group label: Sof-Riba
other name: sovaldi , mpiviropack
intervention type: Drug
intervention name: Ribavirin
description: Ribavirin 1000-1200 mg daily
arm group label: Sof- Riba- Pegylated interferon
arm group label: Sof-Riba
other name: Rebetol, Riba
intervention type: Drug
intervention name: Pegylated-interferon alfa-2a
description: Pegylated interferon alfa-2a once weekly for 3 months
arm group label: Sof- Riba- Pegylated interferon
other name: peginteron, pegasys
intervention type: Drug
intervention name: Simeprevir
description: Olysio once daily.
arm group label: Sof- Olysio
other name: Olysio
intervention type: Drug
intervention name: Daclatasvir
description: Dakla once daily for three months.
arm group label: Sof- Dacla
other name: Daklatasvir, Dakla
intervention type: Drug
intervention name: Ritaprevir, paritaprevir, ombetasvir
description: Querevo for three months
arm group label: Ritaprevir, paritaprevir, ombetasvir
other name: querevo
intervention type: Drug
intervention name: Sofosbuvir and Ledipasvir
description: Once daily for three months
arm group label: Harvony
other name: Harvony
intervention type: Drug
intervention name: Salvage therapy
description: three months in repeated treatment failure
arm group label: Salvage therapy
other name: Sofosbuvir,simeprevir, daclatasvir, ribavirin or sofosbuvir and querevo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Asem Elfert, Prof
role: Study Chair
affiliation: Tanta university hospital
last name: Lobna Abo ALi, Ass Prof
role: Study Chair
affiliation: Tanta university hospital
last name: Sabry Abou Saif, Ass Prof
role: Study Chair
affiliation: Tanta university hospital
last name: Taher Eldemerdash, Prof
role: Study Chair
affiliation: Tanta University hospital
last name: Hala M Elsabagh, Prof
role: Study Chair
affiliation: Tanta University hospital
last name: Mohamed Elkassas, Lecturer
role: Study Chair
affiliation: Helwan University
last name: Eslam Esmail, Ass Lecturer
role: Study Chair
affiliation: Tanta University
last name: Sherief Abd-Elsalam
role: Principal Investigator
affiliation: Tanta University
facility: 
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: Sherief Abd-Elsalam
investigator title: Principle investigator
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Interferons
mesh term: Ribavirin
mesh term: Interferon-alpha
mesh term: Interferon alpha-2
mesh term: Peginterferon alfa-2a
mesh term: Sofosbuvir
mesh term: Ledipasvir
mesh term: Simeprevir
mesh term: Ledipasvir, sofosbuvir drug combination
sharing ipd: No