Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-24 @ 5:07 PM
NCT ID:
NCT04739150
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04739150
Study Brief:
Protocol Section:
NCT04739150