<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/NCT02991612</url>
  </required_header>
  <id_info>
    <org_study_id>ZS-CSY-RFXM</org_study_id>
    <nct_id>NCT02991612</nct_id>
  </id_info>
  <brief_title>Rifaximin in Patients With Gastroesophageal Variceal Bleeding</brief_title>
  <acronym>RFXM</acronym>
  <official_title>Efficacy of Rafiximin in Patients With Cirrhotic Gastroesophageal Variceal Hemorrhage: A Single-center Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the safety and efficacy of Rifaximin in the treatment&#xD;
      of cirrhotic gastroesophageal variceal bleeding.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gastroesophageal variceal bleeding is the most common and life-threatening condition in&#xD;
      patients with portal hypertension, which are susceptibility to bacterial infection.&#xD;
&#xD;
      However, the prophylaxis use of antibiotics remained uncertain and lack of high level&#xD;
      evidences.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 25, 2016</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">December 22, 2017</primary_completion_date>
  <phase>N/A</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>Incidence of all clinical adverse events</measure>
    <time_frame>8 weeks</time_frame>
    <description>The occurrence of rebleeding, ascites fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death in 8 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of portal vein thrombosis</measure>
    <time_frame>2 months</time_frame>
    <description>complete or partial recanalization of thrombosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of intestinal flora</measure>
    <time_frame>2 months</time_frame>
    <description>Metagenomics sequencing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changes of serum level of cytokines</measure>
    <time_frame>8 weeks</time_frame>
    <description>Cytokines including TNF-α, IL-1β, IL-2R, IL-6 and IL-10, etc</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Cirrhosis</condition>
  <condition>Esophageal and Gastric Varices</condition>
  <condition>Gastrointestinal Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Rifaximin Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rifaximin 400mg bid for 2 months,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Receive routine endoscopic treatment without having rifaximin for 2 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rifaximin</intervention_name>
    <description>Patients receive Rifaximin 400mg bid for 2 months</description>
    <arm_group_label>Rifaximin Treatment Group</arm_group_label>
    <other_name>XIFAXAN</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 y.o. ≤age≤75 y.o.;&#xD;
&#xD;
          -  Cirrhotic gastroesophageal variceal bleeding underwent endoscopic treatment (include&#xD;
             esophageal varices ligation, endoscopic injection sclerosis and gastric N-&#xD;
             butyl-cyanoacrylate injection).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;18 y.o. or age &gt; 75 y.o.;&#xD;
&#xD;
          -  Never had the variceal bleeding episode before;&#xD;
&#xD;
          -  Do not have endoscopic treatment;&#xD;
&#xD;
          -  Combined with other malignant tumors (not exclude patients with hepatocellular&#xD;
             carcinoma who don't need treatment at the moment);&#xD;
&#xD;
          -  Known infection after endoscopic treatment (Fever, microbial cultures positive, et&#xD;
             al.)&#xD;
&#xD;
          -  Massive ascites or combined with other high-risk factors that require prophylaxis use&#xD;
             of antibiotics.&#xD;
&#xD;
          -  Acute variceal bleeding within 5 days.&#xD;
&#xD;
          -  Refuse to participate&#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>Shiyao CHEN, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhongshan Hospital, Fudan University, Shanghai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>180 Fenglin Road</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 10, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>May 4, 2018</last_update_submitted>
  <last_update_submitted_qc>May 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Zhongshan Hospital</investigator_affiliation>
    <investigator_full_name>Shiyao Chen</investigator_full_name>
    <investigator_title>Professor</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>
    <mesh_term>Gastrointestinal Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rifaximin</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/NCT02991612
org study id: ZS-CSY-RFXM
nct id: NCT02991612
lead sponsor: 
has dmc: No
The purpose of the study is to evaluate the safety and efficacy of Rifaximin in the treatment
      of cirrhotic gastroesophageal variceal bleeding.
Gastroesophageal variceal bleeding is the most common and life-threatening condition in
      patients with portal hypertension, which are susceptibility to bacterial infection.

      However, the prophylaxis use of antibiotics remained uncertain and lack of high level
      evidences.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of all clinical adverse events
time frame: 8 weeks
description: The occurrence of rebleeding, ascites fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death in 8 weeks
measure: Changes of portal vein thrombosis
time frame: 2 months
description: complete or partial recanalization of thrombosis
measure: Changes of intestinal flora
time frame: 2 months
description: Metagenomics sequencing
measure: The changes of serum level of cytokines
time frame: 8 weeks
description: Cytokines including TNF-α, IL-1β, IL-2R, IL-6 and IL-10, etc
arm group label: Rifaximin Treatment Group
arm group type: Experimental
description: Rifaximin 400mg bid for 2 months,
arm group label: Control Group
arm group type: No Intervention
description: Receive routine endoscopic treatment without having rifaximin for 2 months
intervention type: Drug
intervention name: Rifaximin
description: Patients receive Rifaximin 400mg bid for 2 months
arm group label: Rifaximin Treatment Group
other name: XIFAXAN
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Shiyao CHEN, M.D.
role: Principal Investigator
affiliation: Zhongshan Hospital, Fudan University, Shanghai
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Zhongshan Hospital
investigator full name: Shiyao Chen
investigator title: Professor
mesh term: Esophageal and Gastric Varices
mesh term: Gastrointestinal Hemorrhage
mesh term: Hemorrhage
mesh term: Rifaximin