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NCT03843892 Clinical Trial

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

Lung Diseases, Interstitial Clinical Trial

Official title:
Expanded Access Use of OFEV (Nintedanib) in Non-IPF Interstitial Lung Disease

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT03843892
Other study ID # 1199-0380
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date October 2020
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• OFEV
twice daily

Locations
Country Name City State
United States Centra Medical Group Bedford Virginia
United States The Lung Research Center, LLC Chesterfield Missouri
United States Inova Fairfax Medical Campus Falls Church Virginia
United States Glacier View Research Institute Kalispell Montana
United States University of Rochester Medical Center Rochester New York
United States Banner University Medical Center Tucson Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

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