Lung Diseases, InterstitialNCT03843892
An Expanded Access Program to Provide Nintedanib to Patients With Non-IPF ILD Who Have no Alternative Treatment Possibilities
A study testing OFEV in people with Lung Diseases, Interstitial, run by Boehringer Ingelheim at 6 sites in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Diseases, Interstitial
- What is being tested?
- OFEV
- How many people
- Not given
- Where
- 6 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- None
Who cannot join
- 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).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Centra Medical Group
Bedford, Virginia, 24523
The Lung Research Center, LLC
Chesterfield, Missouri, 63017
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
Glacier View Research Institute
Kalispell, Montana, 59901
University of Rochester Medical Center
Rochester, New York, 14559
Banner University Medical Center Tucson
Tucson, Arizona, 85724
About this study
Official title: 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.
- Conditions
- Lung Diseases, Interstitial
- Being tested
- OFEV
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OFEVDrug
twice daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Diseases, InterstitialStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843892
- Sponsor's protocol ID
- 1199-0380
- Status last verified
- Dec 2024
- First submitted
- 14 Feb 2019
- Last updated
- 10 Dec 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Use of OFEV (Nintedanib) in Non-IPF Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT03843892
- Acronym / sponsor ID
- 1199-0380
- Conditions
- Lung Diseases, Interstitial
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- None
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OFEVtwice daily | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OFEV in people with Lung Diseases, Interstitial, run by Boehringer Ingelheim at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.