Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    400
  • sponsor
    Boehringer Ingelheim
Updated on 28 January 2022
cancer
nintedanib
idiopathic pulmonary fibrosis
pirfenidone

Summary

This is an active surveillance study to monitor the real world safety of nintedanib in Indian patients with Idiopathic Pulmonary Fibrosis. The safety of nintedanib has been assessed in clinical trials.This active surveillance aims to collect the safety data of 200 IPF patients treated with nintedanib in approved indication after the commercial availability of the drug in India (23rd January 2017). The objective is to look at safety of nintedanib in the real world setting.

Details
Condition Idiopathic Pulmonary Fibrosis
Clinical Study IdentifierNCT03047031
SponsorBoehringer Ingelheim
Last Modified on28 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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