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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type 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.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: 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.	NCT03047031
Phase 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.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Boehringer Ingelheim
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	India
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis
Study Website:	View Trial Website

Arms & Interventions

Arms

: Group A

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.

: Group B

Patients who started treatment with nintedanib after 23rd January, 2017 and are continuing the drug at the time of participation in the active surveillance.

: Group C

Patients who have been newly prescribed nintedanib at the time of participation in the active surveillance

Interventions

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.