- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02171156
Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis (EAP)
Multi-center Open-label Expanded Access Program of Oral Nintedanib 150 mg Twice Daily in Patients With Idiopathic Pulmonary Fibrosis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Expanded Access Type
- Treatment IND/Protocol
Contacts and Locations
Study Locations
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Florida
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Winter Park, Florida, United States
- 1199.177.1003 Boehringer Ingelheim Investigational Site
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Illinois
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Skokie, Illinois, United States
- 1199.177.1012 Boehringer Ingelheim Investigational Site
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Indiana
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Muncie, Indiana, United States
- 1199.177.1014 Boehringer Ingelheim Investigational Site
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Minnesota
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Minneapolis, Minnesota, United States
- 1199.177.1002 Boehringer Ingelheim Investigational Site
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South Carolina
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Charleston, South Carolina, United States
- 1199.177.1011 Boehringer Ingelheim Investigational Site
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Spartanburg, South Carolina, United States
- 1199.177.1022 Boehringer Ingelheim Investigational Site
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Texas
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Houston, Texas, United States
- 1199.177.1067 Boehringer Ingelheim Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Signed Informed Consent consistent with ICH-GCP and local laws signed prior to entry into the trial;
- Male or female patients aged >=40 years at Visit 1;
- 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;
- Carbon monoxide diffusing capacity (DLCO)(corrected for Haemoglobin (Hb)): 30%-79% predicted of normal, per institutional standards at the clinic site, at Visit 1;
- Forced Vital Capacity (FVC) >= 50% predicted of normal, per institutional standards at the clinic site, at Visit 1.
Exclusion criteria:
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).
- ALT, AST > 1.5 times upper limit of normal (ULN);
- Total Bilirubin > 1.5 times upper limit of normal (ULN);
Bleeding risk:
- 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);
- history of hemorrhagic central nervous system (CNS) event within 12 months of Visit 1;
any of the following within 3 months of Visit 1;
- hemoptysis or haematuria
- active gastro-intestinal bleeding or ulcers
- major injury or surgery
coagulation parameters:
- international normalised ratio (INR) > 2
- prothrombin time (PT) and partial thromboplastin time (PTT) > 150% of institutional upper limit of normal (ULN)
- Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery;
Thrombotic risk:
- known inherited predisposition to thrombosis
- history of thrombotic event (including stroke and transient ischemic attacks) within 12 months of Visit 1;
Cardiac disease:
- Myocardial infarction within 6 months of Visit 1
- Unstable angina within 1 month of Visit 1;
- Current or planned usage (during the course of this trial) of any other investigational drug during the course of this trial;
- 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);
- Permanent discontinuation of nintedanib within a clinical trial, due to adverse events considered drug-related;
- Known hypersensitivity to nintedanib or its excipients;
- 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;
- Alcohol or drug abuse which in the opinion of the treating physician would interfere with participation;
- Women (of child-bearing potential) who are unwilling to use acceptable methods of contraception;
- Pregnancy or breast feeding (female patients must have a negative pregnancy test (ß-HCG test in urine or serum) prior to commencing trial treatment).
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1199.177
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Idiopathic Pulmonary Fibrosis
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St. Antonius HospitalZonMw: The Netherlands Organisation for Health Research and Development; Boeringer...RecruitingPulmonary Fibrosis Idiopathic FamilialNetherlands
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Wake Forest University Health SciencesMayo Clinic; The University of Texas Health Science Center at San AntonioCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
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Sheba Medical CenterUnknownIDIOPATHIC PULMONARY FIBROSISIsrael
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Theravance BiopharmaTerminatedIdiopathic Pulmonary Fibrosis (IPF)United Kingdom
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University of California, San FranciscoCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
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BiogenCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
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Liminal BioSciences Ltd.CompletedIdiopathic Pulmonary Fibrosis (IPF)Canada
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Bristol-Myers SquibbCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
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Angion Biomedica CorpNot yet recruitingIdiopathic Pulmonary Fibrosis (IPF)
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Xfibra, Inc.Not yet recruitingIdiopathic Pulmonary Fibrosis (IPF)
Clinical Trials on nintedanib
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Boehringer IngelheimCompletedCarcinoma, HepatocellularJapan
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Boehringer IngelheimCompleted
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Boehringer IngelheimCompletedHealthyUnited Kingdom
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Sixth Affiliated Hospital, Sun Yat-sen UniversityNot yet recruiting
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Wake Forest University Health SciencesBoehringer IngelheimTerminated
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Boehringer IngelheimCompletedIdiopathic Pulmonary FibrosisSpain, Korea, Republic of, Belgium, Czechia, Australia, Germany, United Kingdom, United States, France, Finland, Japan, Poland, Hungary
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Boehringer IngelheimActive, not recruitingLung Diseases, InterstitialUnited States, Spain, United Kingdom, Canada, Finland, Norway, Italy, Argentina, Belgium, Brazil, Czechia, France, Greece, Mexico, Poland, Germany, Portugal
-
Boehringer IngelheimNo longer availableLung Diseases, Interstitial (in Pediatric Populations) | Childhood Interstitial Lung Disease (chILD)
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Boehringer IngelheimNo longer availableIdiopathic Pulmonary FibrosisBrazil
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Boehringer IngelheimActive, not recruitingLung Diseases, InterstitialChina