<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/NCT03761082</url>
  </required_header>
  <id_info>
    <org_study_id>ID-PIR-401</org_study_id>
    <nct_id>NCT03761082</nct_id>
  </id_info>
  <brief_title>Post Marketing Surveillance of PIRESPA® TAB 200mg (Pirfenidone) for Evaluating the Safety and Efficacy</brief_title>
  <official_title>Post Marketing Surveillance of PIRESPA® TAB 200mg (Pirfenidone) for Evaluating the Safety and Efficacy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IlDong Pharmaceutical Co Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IlDong Pharmaceutical Co Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-marketing surveillance of Pirfenidone&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pirfenidone (Pirespa®) is an anti fibrotic drug, which was approved in 2012 in the Republic&#xD;
      of Korea for the treatment of patients with idiopathic pulmonary fibrosis (IPF). A&#xD;
      post-marketing survey was conducted following the approval to obtain data on the safety and&#xD;
      efficacy of pirfenidone for IPF treatment in real-world practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The change from baseline to week 48 in the percentage of the predicted FVC</measure>
    <time_frame>up to 48 weeks</time_frame>
    <description>In case of administering this drug for more than 12 weeks after registration in the investigation, response evaluation is conducted every 12 weeks (12,24,36,48 weeks) and records are investigated before administration of this drug and after 12, 24,36,48 weeks of administration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse event after this drug administration in general medical</measure>
    <time_frame>48 weeks</time_frame>
    <description>Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period.&#xD;
Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events.</description>
  </secondary_outcome>
  <enrollment type="Actual">258</enrollment>
  <condition>Idiopathic Pulmonary Fibrosis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NA(observation study)</intervention_name>
    <description>NA(observation study)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        residents of Korea, in real-world practice&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Among patients diagnosed as idiopathic pulmonary fibrosis, only those who have used&#xD;
             the testing drug under the general medical conditions for a certain investigation&#xD;
             period after the beginning of the investigation and also signed a the &quot;Personal&#xD;
             Information Utilization Agreement&quot; form. However, for those who have already received&#xD;
             the drug before the beginning of the investigation, only the subjects whose medical&#xD;
             record can be used are included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who is hypersensitive to the active ingredient or additives of this drug&#xD;
&#xD;
          2. Subjects who have severe hepatopathy&#xD;
&#xD;
          3. Subjects who have severe renal disorder (creatinine clearance&lt;30mL/min) or a terminal&#xD;
             renal disease treated by dialysis&#xD;
&#xD;
          4. Subjects who received a combined treatment of fluvoxamine&#xD;
&#xD;
          5. Subjects who have genetic problems, such as galactose intolerance, Lapp lactase&#xD;
             deficiency or glucose-galactose malabsorption&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 24, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>July 8, 2019</last_update_submitted>
  <last_update_submitted_qc>July 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2019</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>Pulmonary Fibrosis</mesh_term>
    <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>not yet discussed on the issue</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/NCT03761082
org study id: ID-PIR-401
nct id: NCT03761082
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Post-marketing surveillance of Pirfenidone
Pirfenidone (Pirespa®) is an anti fibrotic drug, which was approved in 2012 in the Republic
      of Korea for the treatment of patients with idiopathic pulmonary fibrosis (IPF). A
      post-marketing survey was conducted following the approval to obtain data on the safety and
      efficacy of pirfenidone for IPF treatment in real-world practice.
observational model: Cohort
time perspective: Prospective
measure: The change from baseline to week 48 in the percentage of the predicted FVC
time frame: up to 48 weeks
description: In case of administering this drug for more than 12 weeks after registration in the investigation, response evaluation is conducted every 12 weeks (12,24,36,48 weeks) and records are investigated before administration of this drug and after 12, 24,36,48 weeks of administration.
measure: Incidence of adverse event after this drug administration in general medical
time frame: 48 weeks
description: Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period.
Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events.
intervention type: Other
intervention name: NA(observation study)
description: NA(observation study)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
sharing ipd: Undecided
ipd description: not yet discussed on the issue