Learn about Research & Clinical Trials
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
- - 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.
- - The safety, efficacy, and pharmacokinetics of nintedanib have not been studied in patients with severe renal impairment (<30 ml/min creatinine clearance).
- - The safety and efficacy of nintedanib have not been investigated in patients with hepatic impairment classified as Child Pugh B and C.
- - The safety and efficacy of Ofev® in children aged 0-18 years have not been established.
- - Hypersensitivity to nintedanib, to peanut or soya, or to any of the excipients listed in section 6.1.
- - 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.
- - Ofev® should not be used in patients with severe pulmonary hypertension.
- - Patients with a recent history of myocardial infarction or stroke.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
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.