Safety and Effectiveness of Nintedanib in Korean Patients
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients diagnosed with idiopathic pulmonary fibrosis
(or) Patients diagnosed with systemic sclerosis associated interstitial lung disease
(or) patients diagnosed with Progressive Fibrosing Interstitial Lung Disease(PF-ILD)
Patients who have been started on Ofev in accordance with the approved label in Korea
Patients who have signed on the data release consent form
Patients for whom nintedanib is contraindicated according local label of Ofev
Patients with known hypersensitivity to Ofev, peanut or soya, or to any of the excipients
Women who are pregnant or nursing
Patients with moderate(Child pugh B) and severe(Child Pugh c) hepatic impairment
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://trials.boehringer-ingelheim.com/trial_results/clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Also, Researchers can use the following link http://trials.boehringer-ingelheim.com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.