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An Expanded Access Program in Belgium to Provide Nintedanib to People With Lung Diseases Called Non-IPF ILDs Who Have no Alternative Treatment Options

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Expanded Access
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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% - 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.

Exclusion Criteria:

  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04739150
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Available
Countries Belgium
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lung Diseases, Interstitial
Study Website: View Trial Website

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Aalst - HOSP Onze-Lieve-Vrouw, Aalst, Belgium

Status

Available

Address

Aalst - HOSP Onze-Lieve-Vrouw

Aalst, , 9300

Site Contact

Valerie Adam

valerie.adam@olvz-aalst.be

+32 53 724289

ULB Hopital Erasme, Anderlecht, Belgium

Status

Available

Address

ULB Hopital Erasme

Anderlecht, , 1070

Antwerpen, Belgium

Status

Available

Address

Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim

Antwerpen, , 2020

Site Contact

Hans Slabbynck

hans.slabbynck@skynet.be

+32 (0)3 280 35 63

AZ Klina, Brasschaat, Belgium

Status

Available

Address

AZ Klina

Brasschaat, , 2930

Site Contact

Winand Van Rompaey

winand.van.rompaey@klina.be

+32 3 6505325

Universitair Ziekenhuis Brussel, Brussel, Belgium

Status

Available

Address

Universitair Ziekenhuis Brussel

Brussel, , 1090

Site Contact

Samuel Debontridder

samuel.debontridder@uzbrussel.be

+32 2 4776012

Brussels - UNIV Saint-Luc, Bruxelles, Belgium

Status

Available

Address

Brussels - UNIV Saint-Luc

Bruxelles, , 1200

Site Contact

Antoine Froidure

antoine.froidure@uclouvain.be

+32 02 7642832

UNIV UZ Gent, Gent, Belgium

Status

Available

Address

UNIV UZ Gent

Gent, , 9000

Site Contact

Guy Brusselle

guy.brusselle@uzgent.be

+32 9 3322672

Jessa Ziekenhuis - Campus Virga Jesse, Hasselt, Belgium

Status

Available

Address

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, , 3500

Site Contact

Jokke Wynants

Jokke.Wynants@jessazh.be

+32 11 699615

Kortrijk - HOSP AZ Groeninge Kennedylaan, Kortrijk, Belgium

Status

Available

Address

Kortrijk - HOSP AZ Groeninge Kennedylaan

Kortrijk, , 8500

Site Contact

Tom Moerman

tom.moerman@azgroeninge.be

+32 56 633340

UZ Leuven, Leuven, Belgium

Status

Available

Address

UZ Leuven

Leuven, , 3000

Site Contact

Wim Wuyts

wim.wuyts@uzleuven.be

+32 16 34 68 02

Liege, Belgium

Status

Available

Address

Centre Hospitalier Universitaire de Liège

Liege, , 4000

Site Contact

Julien Guiot

J.Guiot@chuliege.be

+32 4 284 49 01

Roeselare - HOSP AZ Delta, Roeselare, Belgium

Status

Available

Address

Roeselare - HOSP AZ Delta

Roeselare, , 8800

Site Contact

Hannelore Bode

Hannelore.Bode@azdelta.be

+32 51 237216

Sint-Niklaas, Belgium

Status

Available

Address

Sint-Niklaas - HOSP AZ Nikolaas (Campus St-Niklaas)

Sint-Niklaas, , 9100

Yvoir - UNIV UCL de Mont-Godinne, Yvoir, Belgium

Status

Available

Address

Yvoir - UNIV UCL de Mont-Godinne

Yvoir, , 5530

Site Contact

Caroline Dahlqvist

caroline.dahlqvist@uclouvain.be

+32 (0) 81 42 33 66