<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/NCT01688024</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00052685</org_study_id>
    <nct_id>NCT01688024</nct_id>
  </id_info>
  <brief_title>Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis</brief_title>
  <official_title>Phase 2 Study of Mitomycin C Therapy for Biliary Strictures in Patients With Primary Sclerosing Cholangitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Li, Zhiping, M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Li, Zhiping, M.D.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effectiveness and safety of mitomycin C in the&#xD;
      treatment of primary sclerosing cholangitis (PSC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2017</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis</measure>
    <time_frame>Two years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients with Adverse Events</measure>
    <time_frame>Two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications</measure>
    <time_frame>Two years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Primary Sclerosing Cholangitis</condition>
  <arm_group>
    <arm_group_label>Mitomycin C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Up to 10 mg administered during each standard of care endoscopic retrograde cholangiography. No more than five mitomycin C applications per every twelve months will be given.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Given during each standard of care endoscopic retrograde cholangiography. No more than five normal saline applications per every twelve months will be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mitomycin C</intervention_name>
    <arm_group_label>Mitomycin C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <arm_group_label>Normal saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 18 or older&#xD;
&#xD;
          -  Previously established diagnosis of primary sclerosing cholangitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists class 4 or greater&#xD;
&#xD;
          -  Serum creatinine &gt;= 1.7 mg/dL, eGFR &lt;= 30 mL/min, or dialysis dependence&#xD;
&#xD;
          -  Serum hemoglobin &lt;= 7 g&#xD;
&#xD;
          -  Left ventricular ejection fraction &lt;= 30%&#xD;
&#xD;
          -  Dyspnea with minimal exertion (or supplemental oxygen dependence)&#xD;
&#xD;
          -  History of bone marrow disease&#xD;
&#xD;
          -  Prior recipient of organ transplantation&#xD;
&#xD;
          -  Ongoing chemotherapy&#xD;
&#xD;
          -  Obstruction of the upper GI tract&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Inability to provide informed consent&#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>Zhiping Li, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Po-Hung Chen, M.D.</last_name>
    <phone>410-502-6072</phone>
    <email>pchen37@jhmi.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tinsay A. Woreta, M.D., M.P.H.</last_name>
    <phone>410-955-2635</phone>
    <email>tworeta1@jhmi.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21288</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Zhiping Li, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>September 6, 2016</last_update_submitted>
  <last_update_submitted_qc>September 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mitomycin C</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangitis</mesh_term>
    <mesh_term>Cholangitis, Sclerosing</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitomycins</mesh_term>
    <mesh_term>Mitomycin</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/NCT01688024
org study id: NA_00052685
nct id: NCT01688024
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine the effectiveness and safety of mitomycin C in the
      treatment of primary sclerosing cholangitis (PSC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis
time frame: Two years
measure: Number of Patients with Adverse Events
time frame: Two years
measure: Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications
time frame: Two years
arm group label: Mitomycin C
arm group type: Experimental
description: Up to 10 mg administered during each standard of care endoscopic retrograde cholangiography. No more than five mitomycin C applications per every twelve months will be given.
arm group label: Normal saline
arm group type: Placebo Comparator
description: Given during each standard of care endoscopic retrograde cholangiography. No more than five normal saline applications per every twelve months will be performed.
intervention type: Drug
intervention name: Mitomycin C
arm group label: Mitomycin C
intervention type: Drug
intervention name: Normal saline
arm group label: Normal saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zhiping Li, M.D.
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Po-Hung Chen, M.D.
phone: 410-502-6072
email: pchen37@jhmi.edu
last name: Tinsay A. Woreta, M.D., M.P.H.
phone: 410-955-2635
email: tworeta1@jhmi.edu
facility: 
status: Recruiting
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Cholangitis
mesh term: Cholangitis, Sclerosing
mesh term: Mitomycins
mesh term: Mitomycin