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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

An Active Surveillance to Monitor the Real World Safety in Indian Patients Prescribed Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047031
• Other study ID #: 1199-0280
• Status: Completed
• Start date: April 5, 2017
• Est. completion date: July 21, 2022

Study information

• Verified date: August 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 21, 2022
• Est. primary completion date: July 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Locations

Country	Name	City	State
India	Gleneagles Global Hospital	Chennai
India	Sri Ramakrishna Hospital	Coimbatore
India	Asthma Bhawan	Jaipur
India	CK Birla Hospitals, The Calcutta Medical Research Institute	Kolkata
India	National Allergy Asthma Bronchitis Institute, Kolkata	Kolkatta
India	King George Medical University	Lucknow
India	Midland Healthcare and Research Centre	Lucknow
India	Bhatia Hospital	Mumbai
India	P.D. Hinduja National Hospital	Mumbai
India	Grant Medical Foundation, Ruby Hall Clinic	Pune

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all Adverse Drug Reactions (ADRs) in nintedanib treated patients		up to 56 weeks
Primary	Incidence of all serious adverse events (SAEs) in nintedanib treated patients		up to 56 weeks
Secondary	Percentage of patients who require dose reductions, interruptions and discontinuation due to adverse events		up to 56 weeks

External Links

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