Clinical trial NCT04739150: An Expanded Access Program in Belgium to Provide Nintedanib to People With Lung Diseases Called Non-IPF ILDs Who Have no Alternative Treatment Options
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)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Lung Diseases, Interstitial
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-02-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief 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. 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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Aalst - HOSP Onze-Lieve-Vrouw
city: Anderlecht
country: Belgium
facility: ULB Hopital Erasme
city: Antwerpen
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Bruxelles
country: Belgium
facility: Brussels - UNIV Saint-Luc
city: Gent
country: Belgium
facility: UNIV UZ Gent
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis - Campus Virga Jesse
city: Kortrijk
country: Belgium
facility: Kortrijk - HOSP AZ Groeninge Kennedylaan
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Roeselare
country: Belgium
facility: Roeselare - HOSP AZ Delta
city: Sint-Niklaas
country: Belgium
facility: Sint-Niklaas - HOSP AZ Nikolaas (Campus St-Niklaas)
city: Yvoir
country: Belgium
facility: Yvoir - UNIV UCL de Mont-Godinne
Study officials:
References: