NCT03843892

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

First QC Date

February 14, 2019

Last Update Submit

December 9, 2024

Conditions

Interventions

OFEVDRUG

twice daily

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • None

You may not qualify if:

  • \- 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Banner University Medical Center Tucson

Tucson, Arizona, 85724, United States

Location

The Lung Research Center, LLC

Chesterfield, Missouri, 63017, United States

Location

Glacier View Research Institute

Kalispell, Montana, 59901, United States

Location

University of Rochester Medical Center

Rochester, New York, 14559, United States

Location

Centra Medical Group

Bedford, Virginia, 24523, United States

Location

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 18, 2019

Last Updated

December 10, 2024

Record last verified: 2024-12

Locations