<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/NCT02230982</url>
  </required_header>
  <id_info>
    <org_study_id>1199.192</org_study_id>
    <nct_id>NCT02230982</nct_id>
  </id_info>
  <brief_title>Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis</brief_title>
  <official_title>Multi-center Open-label Expanded Access Program of Oral Nintedanib 150 mg Twice Daily in Patients With Idiopathic Pulmonary Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To provide early access and to evaluate the safety and tolerability of nintedanib in patients&#xD;
      with idiopathic pulmonary fibrosis (IPF)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <condition>Idiopathic Pulmonary Fibrosis</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nintedanib</intervention_name>
    <description>soft gelatin capsule</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Signed Informed Consent consistent with ICH-GCP and local laws signed prior to entry&#xD;
             into the trial;&#xD;
&#xD;
          2. Male or female patients aged &gt;=40 years at Visit 1;&#xD;
&#xD;
          3. IPF diagnosis based upon the American Thoracic Society (ATS)/European Respiratory&#xD;
             Society (ERS) /Japanese Respiratory Society (JRS)/Latin American Thoracic Society&#xD;
             (ALAT) IPF 2011 guideline within 5 years of visit 1;&#xD;
&#xD;
          4. Carbon monoxide diffusing capacity (DLCO) (corrected for Haemoglobin (Hb)): 30%-79%&#xD;
             predicted of normal, per institutional standards at the clinic site, at Visit 1;&#xD;
&#xD;
          5. Forced Vital Capacity (FVC) &gt;= 50% predicted of normal, per institutional standards at&#xD;
             the clinic site, at Visit 1.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Eligible to participate or participating in an ongoing actively accruing clinical&#xD;
             trial with nintedanib in the treatment of IPF.&#xD;
&#xD;
             Laboratory parameters from Visit 1 must satisfy entry criteria as shown below.&#xD;
             Abnormal laboratory parameters may be re-tested if a measurement error is suspected&#xD;
             (e.g., there was no abnormal result of this test in the recent history of the patient&#xD;
             and there is no related clinical sign). The results of the re-test should be reported&#xD;
             within the Screening period (i.e., 28 days of signing the informed consent form).&#xD;
&#xD;
          2. ALT, AST &gt; 1.5 times upper limit of normal (ULN);&#xD;
&#xD;
          3. Total Bilirubin &gt; 1.5 times upper limit of normal (ULN);&#xD;
&#xD;
          4. Bleeding risk:&#xD;
&#xD;
               1. patients who require: fibrinolysis, full-dose therapeutic anticoagulation (e.g.&#xD;
                  vitamin K antagonists, dabigatran, heparin, hirudin, etc.), or high-dose&#xD;
                  antiplatelet therapy. Exceptions: prophylactic low dose heparin or heparin flush&#xD;
                  as needed for maintenance of an indwelling intravenous device (e.g., enoxaparin&#xD;
                  4000 IU s.c. per day) and prophylactic use of antiplatelet therapy (e.g.,&#xD;
                  acetylsalicylic acid up to 325 mg/d, or clopidogrel at 75 mg/d, or equivalent&#xD;
                  doses of other antiplatelet therapy);&#xD;
&#xD;
               2. history of hemorrhagic central nervous system (CNS) event within 12 months of&#xD;
                  Visit 1;&#xD;
&#xD;
               3. any of the following within 3 months of Visit 1;&#xD;
&#xD;
                    -  hemoptysis or haematuria&#xD;
&#xD;
                    -  active gastro-intestinal bleeding or ulcers&#xD;
&#xD;
                    -  major injury or surgery&#xD;
&#xD;
               4. coagulation parameters:&#xD;
&#xD;
                    -  international normalised ratio (INR) &gt; 2&#xD;
&#xD;
                    -  prothrombin time (PT) and partial thromboplastin time (PTT) &gt; 150% of&#xD;
                       institutional upper limit of normal (ULN)&#xD;
&#xD;
          5. Planned major surgery within the next 3 months, including lung transplantation, major&#xD;
             abdominal or major intestinal surgery;&#xD;
&#xD;
          6. Thrombotic risk:&#xD;
&#xD;
               1. known inherited predisposition to thrombosis&#xD;
&#xD;
               2. history of thrombotic event (including stroke and transient ischemic attacks)&#xD;
                  within 12 months of Visit 1;&#xD;
&#xD;
          7. Cardiac disease:&#xD;
&#xD;
               1. Myocardial infarction within 6 months of Visit 1&#xD;
&#xD;
               2. Unstable angina within 1 month of Visit 1;&#xD;
&#xD;
          8. Current or planned usage (during the course of this trial) of any other&#xD;
             investigational drug during the course of this trial;&#xD;
&#xD;
          9. Current or planned treatment (during the course of this trial) with: pirfenidone,&#xD;
             azathioprine, cyclophosphamide, cyclosporine, prednisone &gt;15 mg daily or &gt; 30 mg every&#xD;
             2 days OR equivalent dose of other oral corticosteroids, as well as those listed in&#xD;
             exclusion criteria #4 (bleeding risk);&#xD;
&#xD;
         10. Permanent discontinuation of nintedanib within a clinical trial, due to adverse events&#xD;
             considered drug-related;&#xD;
&#xD;
         11. Known hypersensitivity to nintedanib or its excipients;&#xD;
&#xD;
         12. A disease or condition which in the opinion of treating physician may put the patient&#xD;
             at risk because of participation in this trial or limit the patient's ability to&#xD;
             participate in this trial;&#xD;
&#xD;
         13. Alcohol or drug abuse which in the opinion of the treating physician would interfere&#xD;
             with participation;&#xD;
&#xD;
         14. Women (of child-bearing potential) who are unwilling to use acceptable methods of&#xD;
             contraception;&#xD;
&#xD;
         15. Pregnancy or breast feeding (female patients must have a negative pregnancy test&#xD;
             (ß-HCG test in urine or serum) prior to commencing trial treatment).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Medico Santa Maria</name>
      <address>
        <city>Barra Mansa</city>
        <zip>27323240</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLARE - Clinica de Pneumologia</name>
      <address>
        <city>Goiania</city>
        <zip>74110-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irmandade da Santa Casa de Misericórdia de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <zip>90035-074</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H.C.da Fac. de Medicina de Ribeirao Preto</name>
      <address>
        <city>Ribeirao Preto</city>
        <zip>14048-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade do Estado do Rio de Janeiro</name>
      <address>
        <city>Rio De Janerio</city>
        <zip>20950-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ana Nery</name>
      <address>
        <city>Salvador</city>
        <zip>40323010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNIFESP Departamento de Medicina de Pneumologia</name>
      <address>
        <city>Sao Paulo - SP</city>
        <zip>04023900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clínicas de Sao Paulo - INCOR</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 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>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nintedanib</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/NCT02230982
org study id: 1199.192
nct id: NCT02230982
lead sponsor: 
To provide early access and to evaluate the safety and tolerability of nintedanib in patients
      with idiopathic pulmonary fibrosis (IPF)
intervention type: Drug
intervention name: nintedanib
description: soft gelatin capsule
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
mesh term: Fibrosis
mesh term: Nintedanib