<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/NCT03260556</url>
  </required_header>
  <id_info>
    <org_study_id>2016-5706</org_study_id>
    <nct_id>NCT03260556</nct_id>
  </id_info>
  <brief_title>Pirfenidone for Progressive Fibrotic Sarcoidosis</brief_title>
  <acronym>PirFS</acronym>
  <official_title>Pirfenidone for Progressive Fibrotic Sarcoidosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Royal Brompton &amp; Harefield NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who meet the inclusion and exclusion criteria will be randomized to be treated with&#xD;
      either placebo or pirfenidone at the current approved dosage for idiopathic pulmonary&#xD;
      fibrosis at a 2:1 pirfenidone to placebo ratio. Patients treated with pirfenidone will be&#xD;
      titrated using the following schedule:&#xD;
&#xD;
      One 267 mg capsules three times a day for two weeks. Two 267 mg capsules three times a day&#xD;
      for two weeks Three 267 mg capsules three times a day thereafter Patients will be instructed&#xD;
      to take all doses of medication with food. Dosage will be titrated on an individual basis&#xD;
      depending on patient tolerance of medication.&#xD;
&#xD;
      Those randomized to placebo will receive the same schedule using placebo tablets.&#xD;
&#xD;
      Block randomization will be done at each site. Liver function tests will be evaluated as&#xD;
      listed above. If the patient has an abnormal liver function test, then the dose will be&#xD;
      adjusted per the company's protocol for commercial drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 27, 2017</start_date>
  <completion_date type="Anticipated">March 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Double blind placebo controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Placebo controlled</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Time until clinical worsening (TCW)</measure>
    <time_frame>two years</time_frame>
    <description>TCW</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in forced vital capacity (FVC)</measure>
    <time_frame>two years</time_frame>
    <description>Change in forced vital capacity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CPI</measure>
    <time_frame>two years</time_frame>
    <description>Change in composite physiologic index</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Sarcoidosis, Pulmonary</condition>
  <arm_group>
    <arm_group_label>Pirfenidone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pirfenidone titrated to three 267 mg tablets three times a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebos</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo titrated to three tablets three times a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pirfenidone</intervention_name>
    <description>Increasing doses</description>
    <arm_group_label>Pirfenidone</arm_group_label>
    <other_name>esbriet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Increasing doses</description>
    <arm_group_label>Placebos</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of sarcoidosis&#xD;
&#xD;
          -  Pulmonary function testing with a Composite Physiologic Index (CPI) score of greater&#xD;
             than 40&#xD;
&#xD;
          -  Patient must have evidence of &gt;20% fibrosis on high resolution cat scan&#xD;
&#xD;
          -  Patients must be on a stable prednisone therapy for sarcoidosis for at least two&#xD;
             months and no change in other immunosuppressives in the two months prior to entry into&#xD;
             study&#xD;
&#xD;
          -  Age greater than 18 and less than 90.&#xD;
&#xD;
          -  Able to provide written informed consent for participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving therapy for precapillary pulmonary hypertension.&#xD;
&#xD;
          -  Patients with liver disease Childs class 3 or 4&#xD;
&#xD;
          -  Patients with a left ventricular ejection fraction of less than 40%&#xD;
&#xD;
          -  Patients receiving more than 20 mg prednisone daily or its equivalent&#xD;
&#xD;
          -  Patients with massive hemoptysis within prior three months. Patients with mycetomas&#xD;
             are eligible as long as no massive hemoptysis in prior three months.&#xD;
&#xD;
          -  Patients with clinically important co-existing disease which in the opinion of the&#xD;
             investigator is likely to affect patient's chance for survival during the course of&#xD;
             the study&#xD;
&#xD;
          -  Patient who is pregnant, lactating, intending to become pregnant during the study, or&#xD;
             child bearing capacity who is not willing to use appropriate birth control methods&#xD;
             approved by investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert P Baughman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cincinnati</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Robert P Baughman, MD</last_name>
    <phone>513-584-5225</phone>
    <email>baughmrp@ucmail.uc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rebecca Reeves</last_name>
    <phone>513-584-5226</phone>
    <email>Rebecca.Klein@UCHealth.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert P Baughman, MD</last_name>
      <phone>513-584-5225</phone>
      <email>bob.baughman@uc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Elyse E Lower</last_name>
      <phone>513-584-3829</phone>
      <email>ELower@ucmail.uc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cincinnati</investigator_affiliation>
    <investigator_full_name>Robert P Baughman</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>pulmonary fibrosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoidosis, Pulmonary</mesh_term>
    <mesh_term>Sarcoidosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pirfenidone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>no plans yet</ipd_description>
  </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/NCT03260556
org study id: 2016-5706
nct id: NCT03260556
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis
Patients who meet the inclusion and exclusion criteria will be randomized to be treated with
      either placebo or pirfenidone at the current approved dosage for idiopathic pulmonary
      fibrosis at a 2:1 pirfenidone to placebo ratio. Patients treated with pirfenidone will be
      titrated using the following schedule:

      One 267 mg capsules three times a day for two weeks. Two 267 mg capsules three times a day
      for two weeks Three 267 mg capsules three times a day thereafter Patients will be instructed
      to take all doses of medication with food. Dosage will be titrated on an individual basis
      depending on patient tolerance of medication.

      Those randomized to placebo will receive the same schedule using placebo tablets.

      Block randomization will be done at each site. Liver function tests will be evaluated as
      listed above. If the patient has an abnormal liver function test, then the dose will be
      adjusted per the company's protocol for commercial drug.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double blind placebo controlled trial
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Placebo controlled
measure: Time until clinical worsening (TCW)
time frame: two years
description: TCW
measure: Change in forced vital capacity (FVC)
time frame: two years
description: Change in forced vital capacity
measure: Change in CPI
time frame: two years
description: Change in composite physiologic index
arm group label: Pirfenidone
arm group type: Active Comparator
description: Pirfenidone titrated to three 267 mg tablets three times a day
arm group label: Placebos
arm group type: Placebo Comparator
description: Placebo titrated to three tablets three times a day
intervention type: Drug
intervention name: Pirfenidone
description: Increasing doses
arm group label: Pirfenidone
other name: esbriet
intervention type: Drug
intervention name: Placebos
description: Increasing doses
arm group label: Placebos
other name: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Robert P Baughman, MD
role: Principal Investigator
affiliation: University of Cincinnati
last name: Robert P Baughman, MD
phone: 513-584-5225
email: baughmrp@ucmail.uc.edu
last name: Rebecca Reeves
phone: 513-584-5226
email: Rebecca.Klein@UCHealth.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Cincinnati
investigator full name: Robert P Baughman
investigator title: Professor
mesh term: Sarcoidosis, Pulmonary
mesh term: Sarcoidosis
mesh term: Pirfenidone
sharing ipd: Undecided
ipd description: no plans yet