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Trial record 76 of 317 for:    "Pulmonary Fibrosis, Idiopathic"

Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis

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. Identifier: NCT02230982
Expanded Access Status : No longer available
First Posted : September 3, 2014
Last Update Posted : February 8, 2019
Information provided by (Responsible Party):
Boehringer Ingelheim

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

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

Intervention Details:
  • Drug: nintedanib
    soft gelatin capsule

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

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).

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 identifier (NCT number): NCT02230982

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Centro Medico Santa Maria
Barra Mansa, Brazil, 27323240
CLARE - Clinica de Pneumologia
Goiania, Brazil, 74110-030
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil, 90035-074
H.C.da Fac. de Medicina de Ribeirao Preto
Ribeirao Preto, Brazil, 14048-900
Universidade do Estado do Rio de Janeiro
Rio De Janerio, Brazil, 20950-000
Hospital Ana Nery
Salvador, Brazil, 40323010
UNIFESP Departamento de Medicina de Pneumologia
Sao Paulo - SP, Brazil, 04023900
Hospital das Clínicas de Sao Paulo - INCOR
Sao Paulo, Brazil, 05403-000
Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim Identifier: NCT02230982     History of Changes
Other Study ID Numbers: 1199.192
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action