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An Expanded Access Program to Provide Nintedanib to Patients With Non-IPF ILD Who Have no Alternative Treatment Possibilities

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ClinicalTrials.gov Identifier: NCT03843892
Expanded Access Status : Available
First Posted : February 18, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
This Expanded Access Program is intended to facilitate the availability of OFEV to patients suffering from non Idiopathic Pulmonary Fibrosis-Interstitial Lung Disease (non IPF-ILD) with a progressive clinical course despite Standard of Care treatment and for whom no satisfactory authorised alternative therapy exists or who cannot enter a clinical trial.

Condition or disease Intervention/treatment
Lung Diseases, Interstitial Drug: OFEV

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access Use of OFEV (Nintedanib) in Non-IPF Interstitial Lung Disease



Intervention Details:
  • Drug: OFEV
    twice daily

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

None

Exclusion Criteria:

- Patients who are eligible for and can participate in an ongoing non Idiopathic Pulmonary Fibrosis-Interstitial Lung Disease (non IPF-ILD) study will be excluded from participation in this Expanded Access Program (EAP).


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): NCT03843892


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

Locations
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United States, Arizona
Banner University Medical Center Tucson
Tucson, Arizona, United States, 85724
Contact: Sachin Chaudhary    +001 (520) 626-8000    sachin@deptofmed.arizona.edu   
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14559
Contact: Robert Kottmann    +001 (585) 275-4861    matt_kottmann@urmc.rochester.edu   
United States, Virginia
Centra Medical Group
Bedford, Virginia, United States, 24523
Contact: Stephen Johnson    +001 (434) 390-4182    Steve.Johnson@Centrahealth.com   
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03843892     History of Changes
Other Study ID Numbers: 1199-0380
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action