<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/NCT03247296</url>
  </required_header>
  <id_info>
    <org_study_id>3132010</org_study_id>
    <nct_id>NCT03247296</nct_id>
  </id_info>
  <brief_title>Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir</brief_title>
  <official_title>Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MTI University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MTI University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the early detection of HCC in patients Taking Sofosbuvir and Daclatasvir.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methodology:&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Prospective, randomized study used to detect early incidence of HCC in patients taking&#xD;
      Sofosbuvir and Daclatasvir to treat HCV.&#xD;
&#xD;
      Patients will be recruited from the National Hepatology and Tropical Medicine Research&#xD;
      Institute (NHTMRI)&#xD;
&#xD;
      Duration of study:&#xD;
&#xD;
      24 weeks from starting the DAAs&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Patients will go through examination and lab. Workup three times in this study:&#xD;
&#xD;
        -  FIRST time:&#xD;
&#xD;
             -  Before starting antiviral therapy, all included patients will undergo through&#xD;
                physical examination, lab workup including HCV-RNA quantitative, fasting plasma&#xD;
                glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin&#xD;
                Concentration or INR, total bilirubin, serum albumin, Pregnancy test ( Ladies in&#xD;
                child bearing period), AFP as a marker of HCC.&#xD;
&#xD;
             -  Included patients will also undergo through diagnostic procedures as Abdominal&#xD;
                ultrasonography and ECG (men &gt;40, women&gt;50).&#xD;
&#xD;
        -  Second time:&#xD;
&#xD;
             -  At the end of antiviral therapy (12 weeks), virological response to therapy will be&#xD;
                assessed by quantitative HCV RNA detection, using PCR.&#xD;
&#xD;
             -  Patients will lab workup including , fasting plasma glucose or HbA1C if diabetic,&#xD;
                serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin,&#xD;
                serum albumin, AFP as a marker of HCC.&#xD;
&#xD;
             -  The abdominal ultrasonography will be repeated any suspected focal lesion of the&#xD;
                liver will be evaluated with triphasic CT scan or MRI to assess the occurrence or&#xD;
                the recurrence of HCC.&#xD;
&#xD;
        -  Third and last time:&#xD;
&#xD;
             -  At 24 weeks ( Patients will be off treatment for the previous 12 weeks) ,&#xD;
                virological response to therapy will be assessed by quantitative HCV RNA detection,&#xD;
                using PCR.&#xD;
&#xD;
             -  Patients will lab workup including, fasting plasma glucose or HbA1C if diabetic,&#xD;
                serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin,&#xD;
                serum albumin, AFP as a marker of HCC.&#xD;
&#xD;
             -  The abdominal ultrasonography will be repeated any suspected focal lesion of the&#xD;
                liver will be evaluated with triphasic CT scan or MRI to assess the occurrence or&#xD;
                the recurrence of HCC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 28, 2017</start_date>
  <completion_date type="Anticipated">November 10, 2017</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>HCC</measure>
    <time_frame>24 weeks</time_frame>
    <description>occurence of HCC</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Patients taking Sofosbuvir and Daclatasvir</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>Patients taking Sofosbuvir,Daclatasvir, and Ribavirin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sofosbuvir 400 mg, Daclatasvir, Ribavirin</intervention_name>
    <description>No intervention made this is an observational study to monitor the already existing protocols of the facility</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients have positive HCV-RNA and taking DAAS to treat it.&#xD;
&#xD;
          -  Both sexes will be included&#xD;
&#xD;
          -  Age above 18 to 75 years old&#xD;
&#xD;
          -  Child Pugh score (A and B)&#xD;
&#xD;
        Patients randomly enrolled in the study from the hepatitis clinic in the National&#xD;
        Hepatology and Tropical Medicine research Institute&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients have positive HCV-RNA and taking DAAS to treat it.&#xD;
&#xD;
          -  Both sexes will be included&#xD;
&#xD;
          -  Age above 18 to 75 years old&#xD;
&#xD;
          -  Child Pugh score ( A and B )&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Total serum bilirubin&lt;3 mg/dl&#xD;
&#xD;
          -  Serum albumin &gt; 2.8 g/dl&#xD;
&#xD;
          -  INR≥ 1.7&#xD;
&#xD;
          -  Platelet count&lt; 50000/mm3 IF any of the above criteria is not caused by liver disease,&#xD;
             the patient can be included in the study.&#xD;
&#xD;
          -  HCC, except 4 weeks after intervention aiming at cure with no evidence of activity by&#xD;
             dynamic imaging (CT or MRI).&#xD;
&#xD;
          -  Extra- hepatic malignancy.&#xD;
&#xD;
          -  Pregnancy or inability to use effective contraception.&#xD;
&#xD;
          -  Inadequately controlled diabetes mellitus (HbA1c&gt;9%).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Nagwa A Sabri, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Professor and Head of Clinical Pharmacy Department Faculty of Pharmacy Ain Shams University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Abd El Rahman El Naggar, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Professor of clinicalpharmacology and Toxicology and Head of clinical pharmacy Department MTI University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hasan A El Garem, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Prof. Dr. of Endemic Medicine, hepatology, and gastroenterology Faculty of Medicine Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aya M Esawy, Assistant Lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Lecturer of clinical pharmacy at faculty of pharmacy MTI university</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sara M Zaki, Lecturer</last_name>
    <role>Study Director</role>
    <affiliation>Lecturer of clinical Pharmacy Faculty of pharmacy Ain-Shams University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>May I Mehrez, Fellow</last_name>
    <role>Study Director</role>
    <affiliation>Fellow of Hepatology Internal Medicine Department (NHTMRI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Hepatology and Tropical Medicine Research Institute</name>
      <address>
        <city>Cairo</city>
        <zip>11796</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 10, 2017</last_update_submitted>
  <last_update_submitted_qc>August 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>MTI University</investigator_affiliation>
    <investigator_full_name>Aya Mohammed Mohammed Essawy</investigator_full_name>
    <investigator_title>Assistant Lecturer</investigator_title>
  </responsible_party>
  <keyword>Daclatasvir</keyword>
  <keyword>HCC</keyword>
  <keyword>HCV</keyword>
  <keyword>Sofosbuvir</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</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>
  </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/NCT03247296
org study id: 3132010
nct id: NCT03247296
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate the early detection of HCC in patients Taking Sofosbuvir and Daclatasvir.
Methodology:

      Design:

      Prospective, randomized study used to detect early incidence of HCC in patients taking
      Sofosbuvir and Daclatasvir to treat HCV.

      Patients will be recruited from the National Hepatology and Tropical Medicine Research
      Institute (NHTMRI)

      Duration of study:

      24 weeks from starting the DAAs

      Methods:

      Patients will go through examination and lab. Workup three times in this study:

        -  FIRST time:

             -  Before starting antiviral therapy, all included patients will undergo through
                physical examination, lab workup including HCV-RNA quantitative, fasting plasma
                glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin
                Concentration or INR, total bilirubin, serum albumin, Pregnancy test ( Ladies in
                child bearing period), AFP as a marker of HCC.

             -  Included patients will also undergo through diagnostic procedures as Abdominal
                ultrasonography and ECG (men >40, women>50).

        -  Second time:

             -  At the end of antiviral therapy (12 weeks), virological response to therapy will be
                assessed by quantitative HCV RNA detection, using PCR.

             -  Patients will lab workup including , fasting plasma glucose or HbA1C if diabetic,
                serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin,
                serum albumin, AFP as a marker of HCC.

             -  The abdominal ultrasonography will be repeated any suspected focal lesion of the
                liver will be evaluated with triphasic CT scan or MRI to assess the occurrence or
                the recurrence of HCC.

        -  Third and last time:

             -  At 24 weeks ( Patients will be off treatment for the previous 12 weeks) ,
                virological response to therapy will be assessed by quantitative HCV RNA detection,
                using PCR.

             -  Patients will lab workup including, fasting plasma glucose or HbA1C if diabetic,
                serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin,
                serum albumin, AFP as a marker of HCC.

             -  The abdominal ultrasonography will be repeated any suspected focal lesion of the
                liver will be evaluated with triphasic CT scan or MRI to assess the occurrence or
                the recurrence of HCC.
observational model: Cohort
time perspective: Prospective
measure: HCC
time frame: 24 weeks
description: occurence of HCC
arm group label: Group A
description: Patients taking Sofosbuvir and Daclatasvir
arm group label: Group B
description: Patients taking Sofosbuvir,Daclatasvir, and Ribavirin
intervention type: Drug
intervention name: Sofosbuvir 400 mg, Daclatasvir, Ribavirin
description: No intervention made this is an observational study to monitor the already existing protocols of the facility
arm group label: Group A
arm group label: Group B
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
last name: Nagwa A Sabri, Professor
role: Study Chair
affiliation: Professor and Head of Clinical Pharmacy Department Faculty of Pharmacy Ain Shams University
last name: Abd El Rahman El Naggar, Professor
role: Study Director
affiliation: Professor of clinicalpharmacology and Toxicology and Head of clinical pharmacy Department MTI University
last name: Hasan A El Garem, Professor
role: Study Director
affiliation: Prof. Dr. of Endemic Medicine, hepatology, and gastroenterology Faculty of Medicine Cairo University
last name: Aya M Esawy, Assistant Lecturer
role: Principal Investigator
affiliation: Assistant Lecturer of clinical pharmacy at faculty of pharmacy MTI university
last name: Sara M Zaki, Lecturer
role: Study Director
affiliation: Lecturer of clinical Pharmacy Faculty of pharmacy Ain-Shams University
last name: May I Mehrez, Fellow
role: Study Director
affiliation: Fellow of Hepatology Internal Medicine Department (NHTMRI)
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: MTI University
investigator full name: Aya Mohammed Mohammed Essawy
investigator title: Assistant Lecturer
mesh term: Hepatitis C
mesh term: Carcinoma, Hepatocellular
mesh term: Ribavirin
mesh term: Sofosbuvir