NO_LONGER_AVAILABLENot Applicable

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

Belgium

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Trial details

NCT IDNCT04739150

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS