- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03843892
An Expanded Access Program to Provide Nintedanib to Patients With Non-IPF ILD Who Have no Alternative Treatment Possibilities
October 28, 2020 updated by: Boehringer Ingelheim
Expanded Access Use of OFEV (Nintedanib) in Non-IPF Interstitial Lung Disease
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.
Study Overview
Status
Approved for marketing
Conditions
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States, 85724
- Banner University Medical Center Tucson
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Missouri
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Chesterfield, Missouri, United States, 63017
- The Lung Research Center, LLC
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Montana
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Kalispell, Montana, United States, 59901
- Glacier View Research Institute
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New York
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Rochester, New York, United States, 14559
- University of Rochester Medical Center
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Virginia
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Bedford, Virginia, United States, 24523
- Centra Medical Group
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Falls Church, Virginia, United States, 22042
- Inova Fairfax Medical Campus
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
February 14, 2019
First Submitted That Met QC Criteria
February 14, 2019
First Posted (Actual)
February 18, 2019
Study Record Updates
Last Update Posted (Actual)
October 30, 2020
Last Update Submitted That Met QC Criteria
October 28, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1199-0380
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.
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