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

Expanded access is currently available for this treatment.
Verified November 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02171156
First received: June 18, 2014
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention
Idiopathic Pulmonary Fibrosis
Drug: nintedanib

Study Type: Expanded Access     What is Expanded Access?
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 NLM:


Further study details as provided by Boehringer Ingelheim:

Study Start Date: August 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: nintedanib
    soft gelatin capsule
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02171156

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
United States, Florida
1199.177.1001 Boehringer Ingelheim Investigational Site
Coral Gables, Florida, United States
1199.177.1026 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
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, New York
1199.177.1004 Boehringer Ingelheim Investigational Site
Jamaica, New York, 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
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02171156     History of Changes
Other Study ID Numbers: 1199.177
Study First Received: June 18, 2014
Last Updated: November 19, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014