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Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis (EAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02171156
Expanded Access Status : Approved for marketing
First Posted : June 24, 2014
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
To provide early access and to evaluate the safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis (IPF).

Condition or disease Intervention/treatment
Idiopathic Pulmonary Fibrosis Drug: nintedanib

Study Design
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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: Multi-center Open-label Expanded Access Program of Oral Nintedanib 150 mg Twice Daily in Patients With Idiopathic Pulmonary Fibrosis

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: nintedanib
    soft gelatin capsule
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Signed Informed Consent consistent with ICH-GCP and local laws signed prior to entry into the trial;
  2. Male or female patients aged >=40 years at Visit 1;
  3. IPF diagnosis based upon the American Thoracic Society (ATS)/European Respiratory Society (ERS) /Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) IPF 2011 guideline within 5 years of visit 1;
  4. Carbon monoxide diffusing capacity (DLCO)(corrected for Haemoglobin (Hb)): 30%-79% predicted of normal, per institutional standards at the clinic site, at Visit 1;
  5. Forced Vital Capacity (FVC) >= 50% predicted of normal, per institutional standards at the clinic site, at Visit 1.

Exclusion criteria:

  1. Eligible to participate or participating in an ongoing actively accruing clinical trial with nintedanib in the treatment of IPF.

    Laboratory parameters from Visit 1 must satisfy entry criteria as shown below. Abnormal laboratory parameters may be re-tested if a measurement error is suspected (e.g., there was no abnormal result of this test in the recent history of the patient and there is no related clinical sign). The results of the re-test should be reported within the Screening period (i.e., 28 days of signing the informed consent form).

  2. ALT, AST > 1.5 times upper limit of normal (ULN);
  3. Total Bilirubin > 1.5 times upper limit of normal (ULN);

  4. Bleeding risk:

    1. patients who require: fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, dabigatran, heparin, hirudin, etc.), or high-dose antiplatelet therapy. Exceptions: prophylactic low dose heparin or heparin flush as needed for maintenance of an indwelling intravenous device (e.g., enoxaparin 4000 IU s.c. per day) and prophylactic use of antiplatelet therapy (e.g., acetylsalicylic acid up to 325 mg/d, or clopidogrel at 75 mg/d, or equivalent doses of other antiplatelet therapy);
    2. history of hemorrhagic central nervous system (CNS) event within 12 months of Visit 1;

    3. any of the following within 3 months of Visit 1;

      • hemoptysis or haematuria
      • active gastro-intestinal bleeding or ulcers
      • major injury or surgery

    4. coagulation parameters:

      • international normalised ratio (INR) > 2
      • prothrombin time (PT) and partial thromboplastin time (PTT) > 150% of institutional upper limit of normal (ULN)
  5. Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery;

  6. Thrombotic risk:

    1. known inherited predisposition to thrombosis
    2. history of thrombotic event (including stroke and transient ischemic attacks) within 12 months of Visit 1;

  7. Cardiac disease:

    1. Myocardial infarction within 6 months of Visit 1
    2. Unstable angina within 1 month of Visit 1;
  8. Current or planned usage (during the course of this trial) of any other investigational drug during the course of this trial;
  9. Current or planned treatment (during the course of this trial) with: pirfenidone, azathioprine, cyclophosphamide, cyclosporine, prednisone >15 mg daily or > 30 mg every 2 days OR equivalent dose of other oral corticosteroids, as well as those listed in exclusion criteria #4 (bleeding risk);
  10. Permanent discontinuation of nintedanib within a clinical trial, due to adverse events considered drug-related;
  11. Known hypersensitivity to nintedanib or its excipients;
  12. A disease or condition which in the opinion of treating physician may put the patient at risk because of participation in this trial or limit the patient's ability to participate in this trial;
  13. Alcohol or drug abuse which in the opinion of the treating physician would interfere with participation;
  14. Women (of child-bearing potential) who are unwilling to use acceptable methods of contraception;
  15. Pregnancy or breast feeding (female patients must have a negative pregnancy test (ß-HCG test in urine or serum) prior to commencing trial treatment).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02171156


Locations
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United States, Florida
1199.177.1003 Boehringer Ingelheim Investigational Site
Winter Park, Florida, United States
United States, Illinois
1199.177.1012 Boehringer Ingelheim Investigational Site
Skokie, Illinois, United States
United States, Indiana
1199.177.1014 Boehringer Ingelheim Investigational Site
Muncie, Indiana, United States
United States, Minnesota
1199.177.1002 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota, United States
United States, South Carolina
1199.177.1011 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
1199.177.1022 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
United States, Texas
1199.177.1067 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02171156    
Other Study ID Numbers: 1199.177
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Nintedanib
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases, Interstitial
 Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action