Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis
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|ClinicalTrials.gov Identifier: NCT03047031|
Recruitment Status : Completed
First Posted : February 8, 2017
Last Update Posted : August 23, 2022
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|Condition or disease|
|Idiopathic Pulmonary Fibrosis|
|Study Type :||Observational|
|Actual Enrollment :||21 participants|
|Official Title:||An Active Surveillance to Monitor the Real World Safety in Indian Patients Prescribed Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis|
|Actual Study Start Date :||April 5, 2017|
|Actual Primary Completion Date :||July 21, 2022|
|Actual Study Completion Date :||July 21, 2022|
Patients who started treatment with nintedanib after 23rd January, 2017 and have permanently discontinued the drug (as decided by the investigator) at the time of participation in the active surveillance.
Patients who started treatment with nintedanib after 23rd January, 2017 and are continuing the drug at the time of participation in the active surveillance.
Patients who have been newly prescribed nintedanib at the time of participation in the active surveillance
- Incidence of all Adverse Drug Reactions (ADRs) in nintedanib treated patients [ Time Frame: up to 56 weeks ]
- Incidence of all serious adverse events (SAEs) in nintedanib treated patients [ Time Frame: up to 56 weeks ]
- Percentage of patients who require dose reductions, interruptions and discontinuation due to adverse events [ Time Frame: up to 56 weeks ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- Patients with documented diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based upon ATS/ERS/JRS/ALAT 2011 guidelines (nintedanib naïve or pirfenidone pre-treated) who have initiated or will initiate nintedanib according to the package insert after the commercial availability of drug in India (23rd January 2017).
- Patients in whom it is possible to obtain voluntary informed consent either from the patient or patient's legally authorised representative (applicable for Group B and C patients).
- Patients in whom data collection is possible from the medical records (applicable for Group A and B patients)
- Further inclusion criteria apply
- Patients who were previously treated with nintedanib.
- Patients who have initiated or will initiate nintedanib concomitantly with pirfenidone..
- Patients who are participating in a clinical trial.
- Further exclusion criteria apply.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047031
|Gleneagles Global Hospital|
|Chennai, India, 600100|
|Sri Ramakrishna Hospital|
|Coimbatore, India, 641044|
|Jaipur, India, 302039|
|CK Birla Hospitals, The Calcutta Medical Research Institute|
|Kolkata, India, 700027|
|National Allergy Asthma Bronchitis Institute, Kolkata|
|Kolkatta, India, 700017|
|King George Medical University|
|Lucknow, India, 226003|
|Midland Healthcare and Research Centre|
|Lucknow, India, 226006|
|Mumbai, India, 400007|
|P.D. Hinduja National Hospital|
|Mumbai, India, 400016|
|Grant Medical Foundation, Ruby Hall Clinic|
|Pune, India, 411001|
|Responsible Party:||Boehringer Ingelheim|
|Other Study ID Numbers:||
|First Posted:||February 8, 2017 Key Record Dates|
|Last Update Posted:||August 23, 2022|
|Last Verified:||August 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing 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 https://www.mystudywindow.com/msw/datasharing 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)
|Time Frame:||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.|
|Access Criteria:||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'.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Idiopathic Pulmonary Fibrosis
Respiratory Tract Diseases