<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/NCT01695174</url>
  </required_header>
  <id_info>
    <org_study_id>11-006516</org_study_id>
    <nct_id>NCT01695174</nct_id>
  </id_info>
  <brief_title>A Pilot Study of Xifaxan to Treat Patients With PSC</brief_title>
  <acronym>PSC</acronym>
  <official_title>A Pilot Study of Xifaxan in Patients With Primary Sclerosing Cholangitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the current protocol, we propose the assessment of potential beneficial effects of the&#xD;
      antibiotic Xifaxan on liver biochemistries, liver related symptoms and Mayo risk score in 15&#xD;
      adult and 5 pediatric patients with PSC. Adult patients will receive Xifaxan, 550 mg twice&#xD;
      daily over a 12-week period. Pediatric patients with PSC whose weight is greater than or&#xD;
      equal to 40 kg will receive Xifaxan, 550 mg twice daily.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in alkaline phosphatase</measure>
    <time_frame>Three months</time_frame>
    <description>An improvement in elevated levels of alkaline phosphatase to less than half of the initial level at study entry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absence of treatment failure</measure>
    <time_frame>Three months</time_frame>
    <description>Absence of treatment failure which is defined as any of the following: death, need for liver transplantation, side effects requiring discontinuation of therapy, worsening of liver biochemistries, voluntary discontinuation for any reason, marked worsening of fatigue or itching.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Primary Sclerosing Cholangitis (PSC)</condition>
  <arm_group>
    <arm_group_label>Xifaxan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Xifaxan 550 mg two times per day for three months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xifaxan</intervention_name>
    <arm_group_label>Xifaxan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Diagnosis of PSC established by all of the following criteria:&#xD;
&#xD;
               -  Alkaline phosphatase &gt;1.5 times upper limit of normal for at least 6 months&#xD;
                  duration&#xD;
&#xD;
               -  Gamma-glutamyl transferase (GGT) &gt;1.5 times upper limit of normal in pediatric&#xD;
                  patients&#xD;
&#xD;
               -  Cholangiography demonstrating intrahepatic and/or extrahepatic biliary&#xD;
                  obstruction, beading, or narrowing consistent with PSC&#xD;
&#xD;
               -  Liver histology in the past (if available for review) with features consistent&#xD;
                  with or diagnostic of PSC&#xD;
&#xD;
          -  Both genders&#xD;
&#xD;
          -  Adults: Ages 18-75 years.&#xD;
&#xD;
          -  Pediatric: Weight &gt; 40 kg&#xD;
&#xD;
          -  Patient's informed consent for study participation&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Treatment with systematic antibiotics, Azulfidine, ursodeoxycholic acid,&#xD;
             corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil,&#xD;
             budesonide, pentoxifylline, tacrolimus, vitamin E or prednisone in the preceding three&#xD;
             months&#xD;
&#xD;
          -  Active drug or alcohol use&#xD;
&#xD;
          -  Prior history of allergic reaction to the antibiotics which will be used in the study&#xD;
&#xD;
          -  Any condition that, in the opinion of the investigator, would interfere with the&#xD;
             patient's ability to complete the study safely or successfully&#xD;
&#xD;
          -  Evidence of decompensated liver disease such as recurrent variceal bleeding,&#xD;
             refractory ascites or spontaneous hepatic encephalopathy&#xD;
&#xD;
          -  Anticipated need for transplantation in one year (Mayo survival model &lt;80% one-year&#xD;
             survival without transplant)&#xD;
&#xD;
          -  Findings highly suggestive of liver disease of other etiology such as chronic&#xD;
             alcoholic liver disease, chronic hepatitis B or C infection, hemochromatosis, Wilson's&#xD;
             disease, 1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary&#xD;
             cirrhosis or secondary sclerosing cholangitis&#xD;
&#xD;
          -  Treatment with any study medications in the preceding three months&#xD;
&#xD;
          -  Pregnancy or current lactation; subjects becoming pregnant during the study despite&#xD;
             all the precautions will be withdrawn and referred to their primary physicians&#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>Jayant Talwalkar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Tabibian JH, Gossard A, El-Youssef M, Eaton JE, Petz J, Jorgensen R, Enders FB, Tabibian A, Lindor KD. Prospective Clinical Trial of Rifaximin Therapy for Patients With Primary Sclerosing Cholangitis. Am J Ther. 2017 Jan/Feb;24(1):e56-e63. doi: 10.1097/MJT.0000000000000102.</citation>
    <PMID>24914504</PMID>
  </results_reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>October 12, 2014</last_update_submitted>
  <last_update_submitted_qc>October 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Jayant A. Talwalkar</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Primary Sclerosing Cholangitis</keyword>
  <keyword>Xifaxan</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>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/NCT01695174
org study id: 11-006516
nct id: NCT01695174
lead sponsor: 
has dmc: No
In the current protocol, we propose the assessment of potential beneficial effects of the
      antibiotic Xifaxan on liver biochemistries, liver related symptoms and Mayo risk score in 15
      adult and 5 pediatric patients with PSC. Adult patients will receive Xifaxan, 550 mg twice
      daily over a 12-week period. Pediatric patients with PSC whose weight is greater than or
      equal to 40 kg will receive Xifaxan, 550 mg twice daily.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in alkaline phosphatase
time frame: Three months
description: An improvement in elevated levels of alkaline phosphatase to less than half of the initial level at study entry
measure: Absence of treatment failure
time frame: Three months
description: Absence of treatment failure which is defined as any of the following: death, need for liver transplantation, side effects requiring discontinuation of therapy, worsening of liver biochemistries, voluntary discontinuation for any reason, marked worsening of fatigue or itching.
arm group label: Xifaxan
arm group type: Experimental
description: Xifaxan 550 mg two times per day for three months
intervention type: Drug
intervention name: Xifaxan
arm group label: Xifaxan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jayant Talwalkar, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
citation: Tabibian JH, Gossard A, El-Youssef M, Eaton JE, Petz J, Jorgensen R, Enders FB, Tabibian A, Lindor KD. Prospective Clinical Trial of Rifaximin Therapy for Patients With Primary Sclerosing Cholangitis. Am J Ther. 2017 Jan/Feb;24(1):e56-e63. doi: 10.1097/MJT.0000000000000102.
PMID: 24914504
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Jayant A. Talwalkar
investigator title: Principal Investigator
mesh term: Cholangitis
mesh term: Cholangitis, Sclerosing
mesh term: Rifaximin