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

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: NCT03843892
Expanded Access Status : Approved for marketing
First Posted : February 18, 2019
Last Update Posted : October 30, 2020
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

Inclusion Criteria:


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 identifier (NCT number): NCT03843892

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United States, Arizona
Banner University Medical Center Tucson
Tucson, Arizona, United States, 85724
United States, Missouri
The Lung Research Center, LLC
Chesterfield, Missouri, United States, 63017
United States, Montana
Glacier View Research Institute
Kalispell, Montana, United States, 59901
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14559
United States, Virginia
Centra Medical Group
Bedford, Virginia, United States, 24523
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Boehringer Ingelheim
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Responsible Party: Boehringer Ingelheim Identifier: NCT03843892    
Other Study ID Numbers: 1199-0380
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases