<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/NCT01697670</url>
  </required_header>
  <id_info>
    <org_study_id>UC1001</org_study_id>
    <nct_id>NCT01697670</nct_id>
  </id_info>
  <brief_title>Photodynamic Therapy for Ulcerative Colitis</brief_title>
  <official_title>A Multicenter, Open Phase II Study to Assess the Effect and Safety of &quot;Low Dose&quot; Photodynamic Therapy in Patients With Moderate to Severe Active Distal Ulcerative Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swiss National Science Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives:&#xD;
&#xD;
      Primary: The primary study objective is to determine a clinical response as assessed by the&#xD;
      Mayo score to low dose PDT in patients with moderate to severe active distal UC.&#xD;
&#xD;
      Secondary: The secondary study objectives are to assess the effect on inflammation and the&#xD;
      safety and tolerability of low dose PDT in patients with moderate to severe active distal UC.&#xD;
&#xD;
      This is a multicenter, open phase II study that will enroll a maximum of 20 eligible patients&#xD;
      with moderate to severe active distal UC. The first 10 eligible patients, the first cohort,&#xD;
      will receive PDT at a 10 Joule per square centimetre (J/cm2) dose intensity. If no clinical&#xD;
      response is observed in the first 7 eligible patients, the study will be stopped due to lack&#xD;
      of efficacy. If at least 1 clinical response is observed in the first 7 patients, the first&#xD;
      cohort will be completed to a total of 10 eligible patients&#xD;
&#xD;
        -  Trial with medicinal product&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subsequently, the following algorithm will apply:&#xD;
&#xD;
        -  &gt;3 clinical responders at SD8, then another 10 patients, the second cohort, will be&#xD;
           exposed to the same PDT dose intensity&#xD;
&#xD;
        -  &lt;3 clinical responders, without adverse proctosigmoidoscopic observations at SD8, then&#xD;
           the second cohort, will be exposed to the next higher PDT dose intensity 15 J/cm2&#xD;
&#xD;
        -  &lt;3 clinical responders, with adverse proctosigmoidoscopic observations at SD8, then the&#xD;
           second cohort, will be exposed to the next lower PDT dose intensity 5 J/cm2&#xD;
&#xD;
        -  The safety will be continuously evaluated throughout the study.&#xD;
&#xD;
      The screening phase consists of 1 week (SD-7 - SD0), the treatment phase of 4 weeks&#xD;
      (SD1-SD29), and the follow-up evaluation phase of 4 weeks (SD30-SD57), equating to an overall&#xD;
      duration of 9 weeks per patient. It is foreseen to have at least 3 participating&#xD;
      investigational sites to complete accrual of the first cohort in 3 months, and the second&#xD;
      cohort, if appropriate in an additional 3 months. In case of low recruitment, extra sites&#xD;
      will be asked for participation. Hence the study duration from study initiation until last&#xD;
      patient whom completed the study is 8 months to reach the primary analysis of the study. The&#xD;
      follow-up analysis will be completed about 3 months later.&#xD;
&#xD;
      Stopping rules:&#xD;
&#xD;
      Requirement for prohibited medication or surgical procedure Requirement to increase the dose&#xD;
      of permitted medication SAE thought to be attributable to PDT Grade III and IV toxicities&#xD;
      (CTC v3.0) thought to be attributable to PDT Patients request to be withdrawn Lost to&#xD;
      follow-up&#xD;
&#xD;
      Investigational Medicinal Device:&#xD;
&#xD;
      All patients will drink 50 ml orange juice containing 15 mg/kg 5-aminolevulinic acid (5-ALA).&#xD;
      After 3 hours, the lesions will be illuminated with red light at 635 nm using a cylindrical&#xD;
      light diffuser (Model RD, Medlight SA) in a white diffusing inflatable balloon catheter&#xD;
      (model CDB OEB, Medlight SA) at a fluence rate of 65.5 mW/cm2 over 153 seconds resulting in a&#xD;
      total light dose of 10 J/cm2. The first cohort will be treated at a ligh&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">December 2012</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>to determine the proportion of patients with moderate to severe active distal UC with a clinical response to low dose PDT in patients at study day (SD) 8. A clinical response is defined as a total Mayo score &lt;2 with no subscore &gt;1.</measure>
    <time_frame>4 weeks</time_frame>
    <description>The screening phase consists of 1 week (SD-7 - SD0), the treatment phase of 4 weeks (SD1-SD29), and the follow-up evaluation phase of 4 weeks (SD30-SD57), equating to an overall duration of 9 weeks per patient. It is foreseen to have at least 3 participating investigational sites to complete accrual of the first cohort in 3 months, and the second cohort, if appropriate in an additional 3 months. In case of low recruitment, extra sites will be asked for participation. Hence the study duration from study initiation until last patient whom completed the study is 8 months to reach the primary analysis of the study. The follow-up analysis will be completed about 3 months later.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">7</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Photodynamic therapy with Gliolan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Laser light illumination with a cylindrical light diffuser (Model RD, Medlight SA) is performed 3 hours after administration of 15 mg/kg 5-aminolevulinic acid (5-ALA, Gliolan)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Photodynamic therapy with Gliolan</intervention_name>
    <description>Laser light illumination with red light at 635 nm using a cylindrical light diffuser (Model RD, Medlight SA) in a white diffusing inflatable balloon catheter (model CDB OEB, Medlight SA) at a fluence rate of 65.5 mW/cm2 over 153 s resulting in a total light dose of 10 J/cm2 is performed 3 hours after administration of 15mg/kg bodyweight Gliolan</description>
    <arm_group_label>Photodynamic therapy with Gliolan</arm_group_label>
    <other_name>5-aminolaevulinic acid (5-ALA)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria: ? An established and documented diagnosis of UC&#xD;
&#xD;
          -  Moderate and severe active distal UC with a Mayo score of 6-10 and proctosigmoidoscopy&#xD;
             score of 2&#xD;
&#xD;
          -  Distal UC as assessed by proctosigmoidoscopy, i.e. major lesions between the sigmoid&#xD;
             colon and rectum with lesions not extending the splenic flexure&#xD;
&#xD;
          -  Glucocorticosteroids, aminosalicylates and certain immunosuppressants are permitted&#xD;
             under specific conditions as defined in the concomitant medication section&#xD;
&#xD;
        Exclusion criteria: ? Have participated in any other investigational study or received an&#xD;
        experimental therapeutic procedure considered to interfere with the study in the 4 weeks&#xD;
        preceding SD1&#xD;
&#xD;
          -  UC complications (e.g. strictures, pouchitis)&#xD;
&#xD;
          -  Use of the following immunosuppressants in 12 weeks preceding SD1: cyclosporine,&#xD;
             thalidomide derivatives, mycophenolate mofetil&#xD;
&#xD;
          -  Use of antibiotics in 2 weeks preceding SD1&#xD;
&#xD;
          -  Use of non steroidal anti-inflammatory drugs (NSAIDs) in 2 weeks preceding SD1&#xD;
&#xD;
          -  Use of anti-tumor necrosis factor (TNF) or other biologics in 8 weeks preceding SD1&#xD;
&#xD;
          -  Porphyria, erythropoietic protoporphyria or hypersensitivity to porphyrins&#xD;
&#xD;
          -  Uncontrolled medical conditions, requiring surgical or pharmacological treatment&#xD;
&#xD;
          -  Inadequate bone marrow reserve: White blood cell (WBC) &lt; 3.5x109/L, neutrophils &lt;&#xD;
             1.0x109/L, thrombocytes &lt; 100x109/L, haemoglobin (Hb) &lt; 8.5 g/dL or coagulation&#xD;
             abnormalities&#xD;
&#xD;
          -  Inadequate liver function: total bilirubin &gt; 1.5 x upper limit of normal values&#xD;
             aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), or alkaline&#xD;
             phosphatase &gt; 2.5 x upper limit of normal&#xD;
&#xD;
          -  Have inadequate renal function, defined by serum creatinine &gt; 250 µmol/L&#xD;
&#xD;
          -  Serious concomitant disease (e.g. severe cardiovascular disease, chronic obstructive&#xD;
             pulmonary disease)&#xD;
&#xD;
          -  History of cancer &lt; 5 years&#xD;
&#xD;
          -  History of alcohol and/or drug abuses&#xD;
&#xD;
          -  Pregnant or lactating women and fertile women unless surgically sterile or using one&#xD;
             highly effective method + a barrier method till the end of the study (SD29)Female&#xD;
             patients must not be pregnant or lactating&#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>Marianne Ortner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich, Division Gastroenterology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marianne Ortner, MD</last_name>
    <email>marianne.ortner@usz.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Gastroenterology and Hepatology</name>
      <address>
        <city>Zurich</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Anna Ortner, MD</last_name>
      <phone>+41 792300891</phone>
      <email>ma.ortner@bluewin.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>November 2, 2012</last_update_submitted>
  <last_update_submitted_qc>November 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aminolevulinic Acid</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/NCT01697670
org study id: UC1001
nct id: NCT01697670
lead sponsor: 
collaborator: 
has dmc: Yes
Objectives:

      Primary: The primary study objective is to determine a clinical response as assessed by the
      Mayo score to low dose PDT in patients with moderate to severe active distal UC.

      Secondary: The secondary study objectives are to assess the effect on inflammation and the
      safety and tolerability of low dose PDT in patients with moderate to severe active distal UC.

      This is a multicenter, open phase II study that will enroll a maximum of 20 eligible patients
      with moderate to severe active distal UC. The first 10 eligible patients, the first cohort,
      will receive PDT at a 10 Joule per square centimetre (J/cm2) dose intensity. If no clinical
      response is observed in the first 7 eligible patients, the study will be stopped due to lack
      of efficacy. If at least 1 clinical response is observed in the first 7 patients, the first
      cohort will be completed to a total of 10 eligible patients

        -  Trial with medicinal product
Subsequently, the following algorithm will apply:

        -  >3 clinical responders at SD8, then another 10 patients, the second cohort, will be
           exposed to the same PDT dose intensity

        -  <3 clinical responders, without adverse proctosigmoidoscopic observations at SD8, then
           the second cohort, will be exposed to the next higher PDT dose intensity 15 J/cm2

        -  <3 clinical responders, with adverse proctosigmoidoscopic observations at SD8, then the
           second cohort, will be exposed to the next lower PDT dose intensity 5 J/cm2

        -  The safety will be continuously evaluated throughout the study.

      The screening phase consists of 1 week (SD-7 - SD0), the treatment phase of 4 weeks
      (SD1-SD29), and the follow-up evaluation phase of 4 weeks (SD30-SD57), equating to an overall
      duration of 9 weeks per patient. It is foreseen to have at least 3 participating
      investigational sites to complete accrual of the first cohort in 3 months, and the second
      cohort, if appropriate in an additional 3 months. In case of low recruitment, extra sites
      will be asked for participation. Hence the study duration from study initiation until last
      patient whom completed the study is 8 months to reach the primary analysis of the study. The
      follow-up analysis will be completed about 3 months later.

      Stopping rules:

      Requirement for prohibited medication or surgical procedure Requirement to increase the dose
      of permitted medication SAE thought to be attributable to PDT Grade III and IV toxicities
      (CTC v3.0) thought to be attributable to PDT Patients request to be withdrawn Lost to
      follow-up

      Investigational Medicinal Device:

      All patients will drink 50 ml orange juice containing 15 mg/kg 5-aminolevulinic acid (5-ALA).
      After 3 hours, the lesions will be illuminated with red light at 635 nm using a cylindrical
      light diffuser (Model RD, Medlight SA) in a white diffusing inflatable balloon catheter
      (model CDB OEB, Medlight SA) at a fluence rate of 65.5 mW/cm2 over 153 seconds resulting in a
      total light dose of 10 J/cm2. The first cohort will be treated at a ligh
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: to determine the proportion of patients with moderate to severe active distal UC with a clinical response to low dose PDT in patients at study day (SD) 8. A clinical response is defined as a total Mayo score <2 with no subscore >1.
time frame: 4 weeks
description: The screening phase consists of 1 week (SD-7 - SD0), the treatment phase of 4 weeks (SD1-SD29), and the follow-up evaluation phase of 4 weeks (SD30-SD57), equating to an overall duration of 9 weeks per patient. It is foreseen to have at least 3 participating investigational sites to complete accrual of the first cohort in 3 months, and the second cohort, if appropriate in an additional 3 months. In case of low recruitment, extra sites will be asked for participation. Hence the study duration from study initiation until last patient whom completed the study is 8 months to reach the primary analysis of the study. The follow-up analysis will be completed about 3 months later.
arm group label: Photodynamic therapy with Gliolan
arm group type: Experimental
description: Intervention: Laser light illumination with a cylindrical light diffuser (Model RD, Medlight SA) is performed 3 hours after administration of 15 mg/kg 5-aminolevulinic acid (5-ALA, Gliolan)
intervention type: Drug
intervention name: Photodynamic therapy with Gliolan
description: Laser light illumination with red light at 635 nm using a cylindrical light diffuser (Model RD, Medlight SA) in a white diffusing inflatable balloon catheter (model CDB OEB, Medlight SA) at a fluence rate of 65.5 mW/cm2 over 153 s resulting in a total light dose of 10 J/cm2 is performed 3 hours after administration of 15mg/kg bodyweight Gliolan
arm group label: Photodynamic therapy with Gliolan
other name: 5-aminolaevulinic acid (5-ALA)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marianne Ortner, MD
role: Principal Investigator
affiliation: University Hospital Zurich, Division Gastroenterology
last name: Marianne Ortner, MD
email: marianne.ortner@usz.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
mesh term: Aminolevulinic Acid