Lung Diseases, InterstitialNCT04739150
An Expanded Access Program in Belgium to Provide Nintedanib to People With Lung Diseases Called Non-IPF ILDs Who Have no Alternative Treatment Options
A study testing nintedanib in people with Lung Diseases, Interstitial, run by Boehringer Ingelheim at 14 sites in Belgium.
Trial summary
This Expanded Access Program in Belgium is open to people with different lung diseases. This program provides a medicine called nintedanib to people who have no alternative treatment options. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Interstitial
- What is being tested?
- nintedanib
- How many people
- Not given
- Where
- 14 sitesBelgium
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is not eligible for a clinical trial running with Ofev® and/or a clinical trial running in the envisaged indication of this program.
- The patient cannot be satisfactorily treated with the approved and commercially available alternative treatments, in accordance with clinical guidelines, because of efficacy and/or safety issues.
- Signed informed consent form
- Age ≥ 18 years
- Patients diagnosed with ILD who fulfilled at least 1 of the following criteria for PF-ILD within 24 months prior to inclusion in this Medical Need Program (MNP):
- Clinically significant decline in Forced Vital Capacity (FVC) % predicted based on a relative decline of ≥10%
Show all 13Show fewer
- Marginal decline in FVC % predicted based on a relative decline of ≥5 to <10% combined with worsening of respiratory symptoms
- Marginal decline in FVC % predicted based on a relative decline of ≥5% to <10% combined with increasing extent of fibrotic changes on chest high resolution computed tomography (HR-CT) imaging
- Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest HR-CT imaging.
- The treating physician must be a qualified pulmonologist with sufficient experience in treating patients with ILD and sufficient knowledge to administer Ofev®, and states to comply with the following requirements to claim this experience:
- Participates/has participated in clinical trials, in the scope of interstitial lung diseases or has fulfilled a residency or fellowship program in ILD
- Is part of a multidisciplinary team, that has treated ≥25 ILD patients within a random uninterrupted timeframe of 24 months
- The multidisciplinary team exists at least of the following specialist physicians with experience in management of interstitial lung diseases: a pulmonologist, a radiologist, a pathologist, and a rheumatologist.
Who cannot join
- The safety, efficacy, and pharmacokinetics of nintedanib have not been studied in patients with severe renal impairment (<30 ml/min creatinine clearance). These patients are therefore excluded from the program.
- The safety and efficacy of nintedanib have not been investigated in patients with hepatic impairment classified as Child Pugh B and C. Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with Ofev® is not recommended.
- The safety and efficacy of Ofev® in children aged 0-18 years have not been established. No data are available. Non-adult patients are therefore excluded.
- Hypersensitivity to nintedanib, to peanut or soya, or to any of the excipients listed in section 6.1. of the SMPC.
- Diagnosis of IPF as Ofev® can be obtained through reimbursed product in this indication.
- Patients at known risk for bleeding including patients with inherited predisposition to bleeding or patients receiving a full dose of anticoagulative treatment were not included in the clinical trials. Non-serious and serious bleeding events, some of which were fatal, have been reported in the post-marketing period (including patients with or without anticoagulant therapy or other medicinal products that could cause bleeding). Therefore, these patients should only be treated with Ofev if the anticipated benefit outweighs the potential risk.
- Ofev® should not be used in patients with severe pulmonary hypertension.
- Patients with a recent history of myocardial infarction or stroke. Further exclusion criteria apply.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Belgium14 sites
Aalst - HOSP Onze-Lieve-Vrouw
Aalst, 9300
ULB Hopital Erasme
Anderlecht, 1070
Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
Antwerp, 2020
AZ Klina
Brasschaat, 2930
Universitair Ziekenhuis Brussel
Brussels, 1090
Brussels - UNIV Saint-Luc
Brussels, 1200
UNIV UZ Gent
Ghent, 9000
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500
Kortrijk - HOSP AZ Groeninge Kennedylaan
Kortrijk, 8500
UZ Leuven
Leuven, 3000
Centre Hospitalier Universitaire de Liège
Liège, 4000
Roeselare - HOSP AZ Delta
Roeselare, 8800
Sint-Niklaas - HOSP AZ Nikolaas (Campus St-Niklaas)
Sint-Niklaas, 9100
Yvoir - UNIV UCL de Mont-Godinne
Yvoir, 5530
About this study
Official title: Medical Need Program With Ofev® (Nintedanib) for the Treatment of Adult Patients With Non-IPF (Idiopathic Pulmonary Fibrosis) Chronic Fibrosing Interstitial Lung Diseases (ILDs) With a Progressive Phenotype (PF-ILD's)
This Expanded Access Program in Belgium is open to people with different lung diseases. This program provides a medicine called nintedanib to people who have no alternative treatment options. They can participate if they have a type of lung disease called non-IPF ILDs (chronic fibrosing interstitial lung diseases with a progressive phenotype other than idiopathic pulmonary fibrosis).
Participants take 2 capsules of nintedanib a day. The treating physician checks the health of the participants and notes health problems that could have been caused by nintedanib. Participants receive nintedanib as long as they benefit or until nintedanib becomes commercially available in Belgium.
For a patient to participate in this program, their treating physician should apply to Boehringer Ingelheim.
- Conditions
- Lung Diseases, Interstitial
- Being tested
- nintedanib
- 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.
nintedanibDrug
Also called Ofev®
nintedanib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
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
- NCT04739150
- Sponsor's protocol ID
- 1199-0447
- Status last verified
- Sep 2022
- First submitted
- 1 Feb 2021
- Last updated
- 9 Sep 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Need Program With Ofev® (Nintedanib) for the Treatment of Adult Patients With Non-IPF (Idiopathic Pulmonary Fibrosis) Chronic Fibrosing Interstitial Lung Diseases (ILDs) With a Progressive Phenotype (PF-ILD's)
- ClinicalTrials.gov ID
- NCT04739150
- Acronym / sponsor ID
- 1199-0447
- Conditions
- Lung Diseases, Interstitial
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- First posted
- 4 Feb 2021 (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 in Belgium is open to people with different lung diseases. This program provides a medicine called nintedanib to people who have no alternative treatment options. They can participate if they have a type of lung disease called non-IPF ILDs (chronic fibrosing interstitial lung diseases with a progressive phenotype other than idiopathic pulmonary fibrosis).
Participants take 2 capsules of nintedanib a day. The treating physician checks the health of the participants and notes health problems that could have been caused by nintedanib. Participants receive nintedanib as long as they benefit or until nintedanib becomes commercially available in Belgium.
For a patient to participate in this program, their treating physician should apply to Boehringer Ingelheim.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The patient is not eligible for a clinical trial running with Ofev® and/or a clinical trial running in the envisaged indication of this program.
- The patient cannot be satisfactorily treated with the approved and commercially available alternative treatments, in accordance with clinical guidelines, because of efficacy and/or safety issues.
- Signed informed consent form
- Age ≥ 18 years
- Patients diagnosed with ILD who fulfilled at least 1 of the following criteria for PF-ILD within 24 months prior to inclusion in this Medical Need Program (MNP):
Key exclusion criteria (8 listed)
- The safety, efficacy, and pharmacokinetics of nintedanib have not been studied in patients with severe renal impairment (<30 ml/min creatinine clearance). These patients are therefore excluded from the program.
- The safety and efficacy of nintedanib have not been investigated in patients with hepatic impairment classified as Child Pugh B and C. Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with Ofev® is not recommended.
- The safety and efficacy of Ofev® in children aged 0-18 years have not been established. No data are available. Non-adult patients are therefore excluded.
- Hypersensitivity to nintedanib, to peanut or soya, or to any of the excipients listed in section 6.1. of the SMPC.
- Diagnosis of IPF as Ofev® can be obtained through reimbursed product in this indication.
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 |
|---|---|---|
| nintedanibAlso: Ofev®nintedanib | 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 9 Sep 2022.
- Related InfoLink provided by the sponsor.
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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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nintedanib in people with Lung Diseases, Interstitial, run by Boehringer Ingelheim at 14 sites in Belgium.
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 13 inclusion and 8 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 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Belgium. 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 9 Sep 2022.