<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/NCT04499898</url>
  </required_header>
  <id_info>
    <org_study_id>nabeela protocol</org_study_id>
    <nct_id>NCT04499898</nct_id>
  </id_info>
  <brief_title>Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding</brief_title>
  <official_title>Randomized Controlled Trial of Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding in Cirrhotic Patients With Arterial Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sherief Abd-Elsalam</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal&#xD;
      bleeding in cirrhotic patients with arterial hypertension&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Randomized controlled trial of carvedilol versus endoscopic band ligation for primary&#xD;
      prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">December 10, 2030</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2030</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with the first variceal bleeding within 1 year</measure>
    <time_frame>1 year</time_frame>
    <description>The number of patients with the first variceal bleeding within 1 year</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">306</enrollment>
  <condition>Esophageal Varices</condition>
  <arm_group>
    <arm_group_label>carvedilol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Carvedilol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Band Ligation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Band Ligation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carvedilol</intervention_name>
    <description>Carvedilol</description>
    <arm_group_label>carvedilol</arm_group_label>
    <other_name>carvid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic band ligation</intervention_name>
    <description>Endoscopic band ligation</description>
    <arm_group_label>Band Ligation</arm_group_label>
    <other_name>band ligation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Aged &gt;18 years&#xD;
&#xD;
               -  Cirrhotic patients with arterial hypertension&#xD;
&#xD;
               -  Endoscopic evidence of medium/large-sized esophageal varices&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • History of variceal bleeding or previous primary prevention of varices.&#xD;
&#xD;
               -  Portal vein thrombosis or previous porto-systemic shunts as TIPS.&#xD;
&#xD;
               -  Patients on drugs affecting portal pressure (beta blockers, nitrates).&#xD;
&#xD;
               -  Advanced cardiovascular disease including acute myocardial infarction,&#xD;
                  atrio-ventricular block, congestive heart failure, chronic peripheral ischemia,&#xD;
                  severe bradycardia.&#xD;
&#xD;
               -  Patients with severe respiratory diseases (COPD, bronchial asthma).&#xD;
&#xD;
               -  Uncontrolled diabetes mellitus&#xD;
&#xD;
               -  Renal impairment&#xD;
&#xD;
               -  Hepatocellular carcinoma&#xD;
&#xD;
               -  Allergy to carvedilol&#xD;
&#xD;
               -  Pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asem Elfert, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Tanta University - Faculty of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nabila Abd El-Nasser Abd El-Wahed El-Gazzar, ass. lect</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tanta University Faculty of medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sherief Abd-Elsalam, ass. prof.</last_name>
    <phone>00201147773440</phone>
    <email>sheriefabdelsalam@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nabila el-gazzar, ass. lect.</last_name>
    <phone>00201147773440</phone>
    <email>sheriefabdelsalam@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sherief Abd-Elsalam</name>
      <address>
        <city>Tanta</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>sherief abd-elsalam, ass. prof</last_name>
      <phone>00201147773440</phone>
      <email>sheroefabdelsalam@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 1, 2020</last_update_submitted>
  <last_update_submitted_qc>August 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Sherief Abd-Elsalam</investigator_full_name>
    <investigator_title>Ass. Prof. Tropical Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal and Gastric Varices</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carvedilol</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/NCT04499898
org study id: nabeela protocol
nct id: NCT04499898
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal
      bleeding in cirrhotic patients with arterial hypertension
A Randomized controlled trial of carvedilol versus endoscopic band ligation for primary
      prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of patients with the first variceal bleeding within 1 year
time frame: 1 year
description: The number of patients with the first variceal bleeding within 1 year
arm group label: carvedilol
arm group type: Experimental
description: Carvedilol
arm group label: Band Ligation
arm group type: Active Comparator
description: Band Ligation
intervention type: Drug
intervention name: Carvedilol
description: Carvedilol
arm group label: carvedilol
other name: carvid
intervention type: Procedure
intervention name: Endoscopic band ligation
description: Endoscopic band ligation
arm group label: Band Ligation
other name: band ligation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Asem Elfert, Prof
role: Study Director
affiliation: Tanta University - Faculty of Medicine
last name: Nabila Abd El-Nasser Abd El-Wahed El-Gazzar, ass. lect
role: Principal Investigator
affiliation: Tanta University Faculty of medicine
last name: Sherief Abd-Elsalam, ass. prof.
phone: 00201147773440
email: sheriefabdelsalam@yahoo.com
last name: Nabila el-gazzar, ass. lect.
phone: 00201147773440
email: sheriefabdelsalam@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Tanta University
investigator full name: Sherief Abd-Elsalam
investigator title: Ass. Prof. Tropical Medicine
mesh term: Esophageal and Gastric Varices
mesh term: Carvedilol
sharing ipd: No