Back to resultsAn Expanded Access Program to Provide Nintedanib to Patients With Non-IPF ILD Who Have no Alternative Treatment Possibilities
Primary Purpose
Lung Diseases, Interstitial
Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
OFEV
Sponsored by
About this trial
This is an expanded access trial for Lung Diseases, Interstitial
Eligibility 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).
Sites / Locations
- Banner University Medical Center Tucson
- The Lung Research Center, LLC
- Glacier View Research Institute
- University of Rochester Medical Center
- Centra Medical Group
- Inova Fairfax Medical Campus
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT03843892
First Posted
February 14, 2019
Last Updated
October 28, 2020
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT03843892
Brief Title
An Expanded Access Program to Provide Nintedanib to Patients With Non-IPF ILD Who Have no Alternative Treatment Possibilities
Official Title
Expanded Access Use of OFEV (Nintedanib) in Non-IPF Interstitial Lung Disease
Study Type
Expanded Access
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Approved for marketing
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Interstitial
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
OFEV
Intervention Description
twice daily
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Banner University Medical Center Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
The Lung Research Center, LLC
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Glacier View Research Institute
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14559
Country
United States
Facility Name
Centra Medical Group
City
Bedford
State/Province
Virginia
ZIP/Postal Code
24523
Country
United States
Facility Name
Inova Fairfax Medical Campus
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Expanded Access Program to Provide Nintedanib to Patients With Non-IPF ILD Who Have no Alternative Treatment Possibilities
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